Unhed StttM Environmental Protection Agency Office of Pesticides and Toxic Subcta Washington DC 20460 Pesticides Guidance for the Reregistration of Pesticide Products Containing Dipropetryn ------- GUIDANCE FOR THE REREGISTRATION OF PESTICIDE PRODUCTS CONTAINING DIPROPETRYN AS THE ACTIVE INGREDIENT EPA CASE NUMBER 224 U.S. ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS WASHINGTON, D.C. 20460 June 1985 ------- TABLE OF CONTENTS Introduction . . . . . . . . . . . . . . . . . • • • • 1 Regulatory Position and Rationale. . . . . . . . . • • [ • Requ1rern for Submission of Generic Data . . . . . . 16 III. Requirement for Submission of Product—Specific Data . • . . . . . . . . . . . . . . . . . • • • • • • 20 IV. Submission of Revised Labeling . . . . . . . . . . . . 144 A. Label Contents . . . . . . . . . . . . . . . . . • 14)4 B. Collateral Information Labeling. . . . . . . . . . 50 V. Instructions for Submission. . • • • • • • • • • . . 51 APPENDICES II— ]. Guide to Bibliography . . . . . . . . . . . . . . . 55 11—2 Bibliography. . . . . . . . . . . . . . . . . . . . 57 11—3 FIFRA §3(c)(2)(B) Summary Sheet - EPA Form 8580—1 . 60 11-4 Certification of Attempt to Enter Into an Agreement with Other Registrants for Development of Data EPA Form 8580—2. . . . . . . , . . . . . . . . . . 61 111—1 Product Specific Data Report (End—Use Products) . 62 IV—l 40 CFR 162.10 Labeling Requirements . . . . . . . 64 IV-2 Table of Labeling Requirements. . . . . . . . . . 77 IV—3 Physical/Chemical Hazards Labeling Statement. . . 80 IV—4 Storage and Disposal Instructions . . . . . . . . 81 i ------- INTRODUCTION 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 adverse effects on the environment. The scientific review, which is not contained in this Guidance Package but is available upon request, 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 hazards that may be 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 neces— sary to protect the public. EPA has the authority under FIFRA see. 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 see. 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 I ------- 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-n, 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 will 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 firm. 2 ------- PRODUCTS SUBJECT TO THE REGISTRATION STANDARDS PROGRAM ACTION(S) REQUIRED TO MAINTAIN REGISTRATION I. Products That Do Not Qualify For The Formulatorts Exemption A. Single Active Ingredient Products* .. .. . . . S S • • • •• • • • . . . . . .. .•I...*••• B. Multiple Active Ingredient Products These products must be reregis— tered. To obtain reregistration, labeling, packaging and data requirements must be satisfied in accordance with the Regis- tration Standards Guidance Document. S. • •I• •S• •I•S•. .S . • S ••• •• •• • •I••I These products will not be 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 The Formulator’s Exemption Only when additional restric- 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 notbe 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 t 11 tt lose their right to qualify for the formulator’s exemption and become subject to the requirements in I-A and B. 3 ------- I. REGULATORY POSITION AND RATIONALE A. INTRODUCTION This Registration Standard describes the regulatory position and rationale of the Environmental Protection Agency (“the Agency”) for all registered manufacturing—use products (MPs) containing dipropetryn as the sole active ingredient. The Agency bases its position and rationale on an evaluation of all MPs and Section 3, 2 )4(c) and intrastate uses registred for dipropetryn. End—use products (EPs) are reviewed only when there are no MPs registered or when the label has been changed significantly from the current accepted label. Mixtures are included only when there is a significant change in the label. After briefly describing the chemical and its uses, this chapter presents the Agency’s regulatory position and rationale, the criteria for registration, acceptable ranges and limits, labeling requirements and the current tolerance. B. DESCRIPTION OF CHEMICAL Dipropetryn is the accepted common name for the compound: 2- (ethylthio)_ ) 4,6_bis(isopropylaminO)—S—trlazine , as determined by the British Standards Institution, International Organization for Standardization, and the Weed Science Society of America. Dipropetryn is marketed under the trade name Sancap® and other names such as: Cototar® and GS—16068. The Chemical Abstracts Service (CAS) Registry number is 141)47—51—7. The Office of Pesti- cide Program’s EPA Chemical Code Number is 10)4)401. Dipropetryn is a crystalline solid at room temperature. The empi- rical formula is C 11 H 21 N 5 S, and its molecular weight is 255.140. The melting point is 1014-106°C. Dipropetryn is soluble in aromatic and chlorinated hydrocarbon solvents; and in water at 20°C (16.0 ppm). [ Dipropetryn is a triazine type herbicide which selectively con- trols pigweed and Russian thistle in cotton grown on sandy soils (sand, loamy sand, and fine sandy loam). Dipropetryn is applied as a preemergence ground application to cotton. 3 Dipropetryn is absorbed by the roots and readily translocated through the xylem to the apical meristem. Its mode—of—action in the weed is inhibition of water photolysis In the photo- synthesis process. Dipropetryn was patented by the Nippon Kayaku Corporation (US Patent No. 3,326,912) in 1967 and was first registered for use by the Ciba-Geigy Corporation In 1973. Currently, technical dipropetryn Is being produced in the United States by the Ciba— Geigy Corporation of Greensboro, N.C. 4 ------- Dipropetryn is available as a technical material at 95.0 % active ingredient for formulation of dipropetryn end—use products. Dipropetryn is available in wettable powder formulations. C. REGULATORY POSITION AND RATIONALE Based on the review and evaluation of all available data and other relevant Information on dipropetryn the Agency has made the following determinations: 1. The available data are Insufficient to indicate that any Of the risk criteria listed in § 162.11(a) of Title 4O of the U.S.Cocle of Federal Regulations have been met or exceeded for the uses of dipr’opetryn at the present time. Rationale: Dipropetryn has low toxicity by the oral, dermal, and eye Irritation routes of exposure. However, two sub chronic feeding studies Indicated that dIpropetryn can cause toxic effects at the higher dose levels. The 19-week rat feeding study indicated that rats dosed with dipropetryn at 0.0 ppm, 400 ppm, 1200 ppm and 4000 ppm had renal calculi, varied proliferation of renal pelvic epithelium, pyelitis and dilation of the renal pelvis at the 1200 ppm level which is the Lowest Effect Level (LEL). The No-Observable--Effect--Level (NOEL) Is 400 ppm. The 1 1 4-week dog feeding study indicated that dogs dosed with dipropetryn at 0.0 ppm, 40O ppm, 1200 ppm and 000 ppm showed toxic effects at the 1200 and 0O0 ppm levels: hematopolesis In the spleen; hematopoletic and mononuclear inflammatory cells In the liver; regenerative tubule epithellum and dilation in the kidneys; gastritis In the Intestinal tract; reduction In tissue In lymph nodes; re- duction In cellularity In bone marrow In males and females The LEL Is 1200 ppm. The NOEL Is 00 ppm. There are no chronic toxicology data to determine long term effects of dipropetryn. Therefore, the Agency will require the following chronic toxicity data: a 90—day rat inhalation toxicity study, a chronic toxicity study in both the rat and dog, an oncogenicity study In both the rat and mouse, a tera- togenicity study in both the rat and rabbit, a two—generation rat reproduction study; a general metabolism study in the rat; the mutageniclty tests: gene mutation in bacteria, gene mutation In mammalian cells in culture, chromosomal aberration analysis in mammalian cells In culture, and DNA damage in mammalian cells in culture. 5 ------- The Agency has concerns about the herbicide’s lack of chronic toxicity data and its use on a food and feed crop when it is structurally related to cyanazine, a s-triazine pesticide that may be regulated as a teratogen. 2. The Agency will not allow any significant new uses* to be established for dipropetryn until the toxicological and residue chemistry data deficiencies identified in Table A have been satisfied. * “Significant new use” is defined in FR 2793i , May 11, 1979. In the case of a new food or feed use, the Agency will generally consider as significant an In- crease in the Theoretical Maximum Residue Contribution of greater than 1%. Rationale: The Agency is unable to complete a tolerance re- assessment of dipropetryn because of extensive residue and toxicology data gaps. EPA needs the data to evaluate the metabolism of dipropetryn and related metabolite(s) in crops and animals, storage stability, and chronic studies in ro- dent and nonrodent species. Any future tolerance granted for dipropetryn must Include any other triazine moiety residues with dipropetryn. In order to determine the dietary Average Daily Intake (ADI), a combined chronic feeding/oncogenicity study must be completed. 3. Products which are substantially similar to registered pro- ducts may be considered for registration, subject to the terms and conditions specified in this document. Rationale: The Agency does not think that new registrations of uses already on the market will increase the risks to the public from exposure to dipropetryn because use of the chemical is confined to a specific geographical area. However, the Agency will not register new products that would significantly increase exposure until the data gaps have been filled. 4. The Agency will require MP8 containing dipropetryn to bear Category III hazard statements and other warning statements as required in the precautionary labeling under O CFR 162.10. Rationale: Acute toxicity studies for dipropetryn showed the following: Toxicity Category III for acute oral, and Toxicity Category IV for acute dermal and acute inhalation, and for dermal and primary eye irritation. 6 ------- 5. Based on available information and the use pattern of dipro- petryn, the Agency does not expect that dipropetryn will contaminate ground water. At this time, the Agency has de— cided not to restrict dipropetryn, nor to include on labeling a ground water advisory statement. Environmental chemistry data were requested in May 198L to characterize dipropetryn’s potential to contaminate ground water; additional Information Is required by this Standard. If these data reveal that dipropetryn is mobile or persistent such that contamination of ground water may occur, the Agency may reconsider these decisions. Rationale: Dipropetryn is structurally similar to other s- triazine herbicides which are known (and have been found) to leach into ground water. Dipropetryn itself has not been found in ground water and is used only on cotton in four high plains states (Texas, Oklahoma, Arizona, and New Mexico). Moreover, the quantity used has been decreasing over the last three years. In those States where it is applied, the ground water table is estimated to be 150—200 feet below the soil surface. Therefore the Agency does not expect that dipropetryn will contaminate ground water supplies. In May 198L , the Agency Issued a Data Call—In Notice requi- ring the following environmental fate data: hydrolysis ( 161—1); photodegradation in water(161—2), on soil (161—3); soil metabolism in aerobic soIl (162—1), In anaerobic soil (162—2); and mobility ( 163-1). Data on photodegradatlon of dipropetryn on soil surfaces (Accession No. 257328) were submitted recently by a registrant In response to the Data Call—In Notice. These data are being reviewed by the Agency at the present time. 6. The Agency is imposing restrictions on rotational crops. The extent of the restrictions will be reconsidered when additional data are received. Rationale: It Is the policy of the Agency to impose restric- tions on planting rotational crops in treated fields, pend- ing the submission of data. This serves to protect the public from Impermissable residues of dipropetryn In food or feed. 7, No endangered species label statements are required. 7 ------- Rationale: The Agency has evaluated dipropetryri under the cot- ton cluster/use patterns for endangered species concerns. Available data show a low order of toxicity suggesting the potential hazard to endangered species is low. Therefore, dipropetryn was not included among the chemicals referred to the Office of Endangered Species (OES), U.S. Fish & Wildlife Service, in the cotton cluster. Currently, there are no Identifiable endangered plants that would be affected by dipropetryn. The Agency believes that the conventional labeling for dipropetryn is adequate to properly inform the users on how to protect any endangered species. 8. The Agency is not requiring a re-entry Interval for currently registered uses of dipropetryn at this time. Rationale: Dipropetryn has low acute toxicity (Category III) and no known chronic effects at the present time. Addi- tionally, the preemergence use of dipropetryn on cotton does not lead to reentry exposure. 8 ------- D. CRITERIA FOR REGISTRATION UNDER THIS DOCUMENT To be subject to this guidance document, MPs must meet the fol- lowing conditions: 1. Contain dipropetryn as the 8ole active ingredient and, 2. Conform to the acute toxicity limits, product compo8itiOfl, and use pattern requirements listed in Section F of this document. 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 Technical grade products must contain at least 95.0 percent dipropetryfl as the sole active Ingredient. Each MP formulation proposed for registration must be fully described with an appro- priate certification of limits. In addition, the active ingredient found in the MPs must be substantially similar to that in currently registered technical products. Any MP not meeting these require- ments will be considered a new product and will not be registerable under this guidance document. 2. Acute Toxicity Limits The Agency will consider registration of products containing dipropetryn, provided that the product labeling bear 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 dipropetryri must be labeled for formulation only into end—use herbicide products for the commodities listed below. [ The attached index entry lists all registered uses, as well as approved maximum application rates and frequencies]. DipropetrYfl, a selective herbicide, Is registered for control of pigweed and Russian thistle on cotton grown on sandy soils in Arizona, New Mexico, Oklahoma and Texas. Currently, dipropetryn is the only preemergence cotton herbicide that can be used on approximately 315,000 acres of sandy and loamy sand soils in Texas and Oklahoma. Other available preemergence cotton herbicides are phytotoxic to cotton on these soil types. 9 ------- F. REQUIRED LABELING All technical grade products, MP5, and EP8 containing dipropetryn must bear appropriate labeling as specified in ê0 CFR § 162.10. Other portions of this guidance package contain specific infor- mation regarding label requirements. In addition to the requirements stated in ItO CFR § 162.10, the following information must appear on the labeling of all products released for shipment after July 30, 1986 and products in the channels of trade after July 30, 1987 . 1. Ingredient Statement The ingredient statement for MPs must list the active in- gredient as: Dipropetryn: 2—(ethylthio)—Lt,6-bis(isopropylamiflO) —s—triazine •• •• • .% 2. Manufacturing—Use Product Statements All products intended for formulation into end-use products must bear the following statement: “This pesticide is toxic to fish. 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 dis- charge 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”. The following environmental hazard statement must appear on all EP products: “Do not apply directly to water. Do not contaminate water by cleaning of equipment or disposal of wastes. In case of spiiis, cover or incorporate spills.” Restrictions on Rotational Crops “Do not plant food and feed crops in dipropetryn—treated fields unless dipropetryri is authorized for use on those crops”. 10 ------- G. TOLERANCE REASSESSMENT Data are not available for calculating the Acceptable Daily Intake (ADI) for dipropetryn. The Agency is unable to complete a full tolerance reassessment because the available dipropetryn toxicology and residue data do not fully support the established tolerance listed below. The metabolism of dipropetryn in animals and plants is not fully understood. Therefore, the Agency is requiring data on the metabolism of dipropetryn and related metabolite(s) in crops and animals, and on storage stability. Additional long term rodent and nonrodent toxicological studies are also required. These data will be used to assess dietary exposure to dipropetryn and may lead to revisions in the existing tolerances. The Agency will not grant any significant pending or new tolerances for dipropetryn until the data are submitted. In the United States, tolerances are currently established in ItO CFR § 180.369 for the combined residues of the herbicide, dipropetryn: 2(ethylthio)—14,6—bis(isoPrOPyla!flinO)—B-triaZifle, in or on the following raw agricultural commodity: Commodity Parts per million Cottonseeds 0.1 International Tolerances Presently, there are no tolerances for residues of dipropetryn on cottonseed in Canada, Mexico, or in the Codex Alimentarius . 11 ------- EPA Index to Pesticide Chemicals DIPROPETRYN* TYPE PESTICIDE : Herbicide FORMULATIONS : Tech (95%) WP (80%) GENERAL WARNINGS AND LIMITATIONS : A selective preemergent herbicide working mainly through root absorption. Irrigation or rainfall after application will enhance weed control. Should weeds develop, a shallow cultivation or rotary hoeing may improve weed control. Cotton growing on alkali soils, caliche outcroppings or where cuts, fills or erosion have exposed calcareous subsoil may be injured by the chemical. Application to emerged cotton will cause crop damage. Make broadcast ground applica- tions in a minimum of 20 gallons of water per acre. Apply by air in a minimum of 2 gallons per acre. TINE REQUIRED FOR CONTROL : Not located. PHYTOTOXICITY TO TARGET WEEDS : Not located. PHYTOTOXICITY TO CROPS : Not located. MODE OF ACTION : Inhibition of photolysis of water in photosynthetic pro- cess. BROADLEAF WEEDS CONTROLLED : PAFACBI redroot pigweed PBDAKBA Russian thistle *Sancap 2—(ethylthio)—4, 6—bis(isopropylamino)—s—triazine Issued: 11—02—84 1—104401—i 12 ------- EPA Index to Pesticide Chemicals DIPB.OPETRYN Site, Dosage Tolerance, Use, Limitations and Formulation (lb a.i./A) AGRICULTURAL CROPS /28007AA Cotton 0.1 ppm (negligible residue) (cottonseed) Do not feed treated forage to livestock or graie treated areas. Rotational crops may be planted 6 months following initial application. Cotton stalks should be disked or plowed under prior to planting a rotational crop. 1.2—2.0 Use limited to sandy soils in AZ, NM, OK and TX. (80% WP) Preemergence. Broadcast or band. Apply to flat— planted, bedded or furrow—planted cotton. Apply band only to furrow—planted cotton, not to exceed the width of the bottom of the furrow. Reduce dosage in proportion to band area actually treat- ed. Apply at planting or within 2 days following planting. If replanting is necessary, do not make a second application in the, same furrow. A second band application is recommended for furrow— planted cotton if the new furrows are formed down the untreated row middles. Use the lower dosage on sand soils, a medium dosage on loamy sand, and the high dosage on fine sandy loams. AERIAL AND TANK MIX APPLICATIONS 9001500 Aerial Application Refer to AGRICULTURAL CROPS Cotton Issued: 11—02—84 1—104401—2 13 ------- EPA Index to Pesticide Chemicals D I PROPETRYN Listing of Registered Pesticide Products by Formulation 95% technical chemical dipropetryn (104401) 000100—00569 80% wettable powder dipropetryn (104401) 000100—00522 Issued: 11—02—84 1—104401—3 14 ------- EPA Index to Pesticide Chemicals DIPROPETRYN Appendix B Listing of Registration Numbers By Site AGRICULTURAL CROPS /28007AA Cotton 000 100—00522 Issued: 11—02—84 1—104401—4 15 ------- II. 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 Organization 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 11 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, regardless 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. 16 ------- 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—3] 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 te8t 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— ) / *1 FIFRA see. 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) 17 ------- OR 14• 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 fide 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)(iil)]; 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. 18 ------- The extension request 8hould state the reasons why you believe that an extension 18 appropriate. While EPA considers your request, YOU mu8t strive to meet the deadline for submitting the required data. 19 ------- 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—14, 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 formulation which is marketed; it usually includes product chemistry data and acute toxicity data. 20 ------- TABLE A GENERIC DATA REQTJIRE7 1ENTS FOR DIPROPETRYN (95 A .1.) lhta Must Be Guideline Citation and Test Guidelines Are t ta Footnote Submitted Within Name of Test Substance Status Required Yes No Number Time Frames Below 1/ Listed §158.120 Product Chemistry Product Identity : 61—i - Product Identity and Disclosure TGAI R [ ] IX] of Ingredient 61—2 - Description of Beginning Materials TGAI R IX] [ ] 2 6 Months and Manufacturing Process 61-3 - Discussion of Formation of TGAI R Li [ ] _____________ Impurities Analysis and Certification of Product Ingredients 62-i - Preliminary Analysis TGAI CR [ ] Li 3 12 Months 62—2 - Certification of Limits AI CR [ ] [ TI 3 12 Months 62-3 - Analytical Method for forcement It AI CR [ X] 1] 3 12 Months of Limits Physical and Chemical Characteristics 63—2 — Color TGAI R I] [ ] _____________ 63-3 - Physical State TGAI R Li [ ] __________ 63-l i - Odor TGAI R [ ] [ ] 2 6 Months 63-5 - Melting Point TGAI R Li [ ] 63-6 - Boiling Point TGAI R [ Ti [ 1 21 ------- TABLE A GENERIC L TA R JIRE24E2fl’S FC1 DIPROPE7flWN (95% A.I.) t ta Must Be Guideline Citation ani Test Guidelines Are t ta Footnote Suhni tted Within t e of st Substance Status Required Ye8 No W,nber Thne Frames Below 1/ Listed §15 . 120 Product nistry (Continued) Pt8ical Q ical Characteristics ( itinued) 63-7 — Density, &ilk Density, or Specific Gravity R c i 63—8 — So lubility ‘1 AI or PA l R ci 63-9 - Vapor Pressure 63-10 - Dissociation constant 63—11 — Octanol/water partition coefficient 63—12 — pH 63—13 — Stability Other Req uirenents : 6i - 1 - Sutinittal of samples PAl PA] PAl AI TGAI 6 Munths 6 Munths TGAI = Technical Grade of the Active Irgredient; PAl = Pure Active Ir redient; H = Required; CR = Conditionally Required 1/ De’ta must be submitted within the Indicated time frame, based on the date of the Guidance t ctxnent. 2/ 6 Nonth Ilie 1 te is January 30, 1986 . / 12 ! bnth Ilie 1 te is July 30, 1986 . 2 / This canpound does not require the submittal of samples at this time. AI H ci R R R 0 R 0 CR [ -] [ ] [ ] 2 2 1 TGAI, PAl 22 ------- TABLE A GENFJ IC DATA REQUIRE7€NTS FOR DIPROPETRYN DDes EPA Have 1)ita Must Additional E Eita To Satisfy This Be Submitted Under 1/ Requirenent? (Yes, Biblic raphic FIFRA § 3(c)(2)(B)? E ta Requirenents Canposition No, or Partially) Citation Time Frames For t ta Submission 2/ §158.125 Residue Ch nistry 171—2 — Ch n1cal Identity ill, 171—3 — Directions for Use 13/ 171—4 — Nature of Residue (Metabolism) — Plants PAIRA Partially 00110374, 00110378 Yes 3/ 2 4 Months - Livestock PAIRA and Plant No Yes 4/5/ 18 Months Metabolites 171-4 - Residue Analytical Method — Plant residues I AI and Metabolites Partially 00036732, 00036740 Yes 5/7/ 24 Months BT - Animal residues ¶ AI and Metabolites No Yes 7/8/ 18 Months 171—4 — Magniti. 1e of the Residue— Residue Studies for Each Food Use - Crop Group: Miscellaneous Caiinodities o Cottonseed — Processed Food/Feed EP Partially 0011037 14, Yes 9/ 214 Months GS0224—001 23 ------- TABLE A GENERIC DATA p EQtJIRF14ENrS 10R DIPROPFTRYN Data Requirement 1/ Ccinpos Ition Does EPA Have Data To Satisfy This Requirement? (Yes, No or Partially) Bibliographic Citation Must Additional Data Be Submitted Under FIFRA S 3(c)(2)(B)? Time Frames for [ ta Submission _____ §158.125 Residue Chemistry — Continued l7l— — Magnitude of the Residue — Residue Studies (continued) -- MeatJl4ilk/Poultry/Eggs !ltlAI or Plant Metabolites No Yes 10/11/ 18 Months - Potable Water - Fish - Irrigated Crops - Food Handling 171-5 - Reduction of Residue 171-6 - Proposed Tolerance 171-7 - Reasonable Grounds in Support of Petition EP EP 1?! EP EP Residue of i V Concern Residue of Concern No No No No No No No 24 ------- TABLE A GENERIC DATA REQ(JIRE74EI 1PS FOR DIPROPE IW(N S158.125 Residue Chemistry — Continued 1/ CanposItion: IIUAI = Technical grade of the active ingredient; PAulA = Pure active ingredient, radiolabelled; TEP = Typical end-use product; EP = End-use product. 2/ Data must be suheiltted within the indicated time frame, based on the date of the Guidance Ducument. o 18 Month Due Date Ia January 30, 1987 . o 214 t bnth Due Date Is July 30, 1987 . 3/ AddItional plant metabolism data are required to reveal the canpiete identity of radioactive residues encountered in cotton plants resulting fran treatment with radiolabeled dipropetryn. 14/ Metabolism studies utilizing ruminants are required. Animals must be dosed with 111 C ring labeled dipropetryn. Distribution and characterization of residues must be determined in milk and tissues. 5/ If the additional metabolism data show the presence of new metabolites, then additional methodology data may be required. 6/ Metabolism studies utilizing chickens are required. Chickens must be dosed with C ring labeled dipropetryn. 7/ When the nature of the dipropetryn residues in plants and animals are adequately understood, the registrant must suttnit appropriate analytical standards [ successful method trial for dipropetryn] to the Agency. 8/ Depending upon the results of plant and animal metabolism data being required, Method AG-137 or other methodology which determines this canpound and/ or other constituents of the terminal residue of dipropetryn on cotton will be required. 9/ If detect ible residues are observed in cottonseed in the metabolism studies and method trials, processing data will be required for cottonseed. Consult the Agency for appropriate test protocol. 10/ When the metabolism and residue studies becane available, conventional feeding s1 udIes on ruminants will be required. 11/ When the metabolism and residue studies beccine available, conventional feeding studies on chickens will be required. T / This use is not pending, nor has it been approved for dipropetryn at the present time. 13/ This requirement is not appropriate for dipropetryn at the present time. T1r/ This requirement has been satisfied. 25 ------- §158.130 Ehvirorinental Fate DEGRADATION S’IUDIES-LAB : 161—1 — Hydrolysis Photodegradatlczi 161—2 — In water 161—3 — On soil 161-44 - In Air ME’TABOLISM S’fiDIES-LAB : 162—1 — Aerobic Soil 162-2 — Anaerobic Soil 162—3 - Anaerobic Aquatic 162—4 — Aerobic Aquatic MOBILITY SIUDIES : 163—1 - Leaching and Adsorption/Desorption 163—2 — Volatility (Lab) 163—3 — Volatility (Field) 1/ Use 2/ t ita Requirenent Ccznposltion Pattern TABLE A GENERIC DATA R3 UIRH4EN S FOR DIPROPEfl YN 1)es EPA Have t ta Tb Satisfy This Require- ment? (Yes, No or Partially) Must Additional t ta Be Submitted Under Bibliographic FIF1 A § 3(c)(2)(B)? Citation Time Frame for I ta Submission 3/ ‘I AI or PAIRA A No - Yes 9 Months ¶lflAI or PAIRA A No - Yes 9 Months !It AI or PAIRA A No - Yes 11/ 9 Months TUAI or PAIRA I/ No ¶ AI or PAIRA A Yes 27 Months ¶1 AI or PAIRA A Yes 27 Months ¶LWJ or PAIRA 10/ No T AI or PAIRA 10/ No ‘RAI or PAIRA Partially GS022 1 4—002 Yes 5/ 12 Months TEP TEP 14/ 14/ 26 No No ------- Soil Aquatic (Sediment) — Forestry - Cinbination and Tank Mixes 164—5 — Soil, rig—term ACC1MJLATIC* &‘1 JDTh : 165—1 - Rotational Crops (Confined) 165—2 — Rotational Crops (Field) 165—3 — Irrigated Crops 165—4 — In Fish 165-5 - In Aquatic Non-Target 0rgani ns PEP PEP PEP PEP PEP PAIRA A PEP A PEP TGAI or PAIRA A PEP Yes 10/ 10/ 9/ 6/ 10/ No 10/ 00036726, 00110378 No No No No No 1/ Use2/ t .ta Requir nent Canposition Pattern TABLE A GENERIC DATA RBY UIRE?4E1s11’S FOR DIFROPETRYN 1)es EPA Have t ta ‘lb Satisfy This Require- ment? (Yes, No or Partially) Must Additional t ta Be Sutmrttted Under Bibl1ogra iic ML1 1 A § 3(c) (2) (B)? Citation Time Frame for t .ta Sut n1ss1on 3/ §158.130 E ivirorinental Fate - Continued DISSIPATI S’1 JDIE -FIE [ D : 164—1 — 164—2 164—3 164—4 A Partially 00103171 Yes 7/8/ Yes 8/ No Yes No 39 Months 50 Months 12 Months 27 ------- TABLE A GENERIC DATA RB UIREMENTS FOR DIPROPETRYN §158 . 130 Environmental Fate — Continued 1/ Composition: AI = Technical grade of the active ingredient; PAIRA = Pure active ingredient, radiolabelled; TEP = Typical end-use product. 2/ The use patterns are coded as follows: ATerrestrial, Food Crop; B=Terrestrial, Non—Food; C=Aquatic, Food Crop; D=Aquatic, Non—Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; H=Dctnestic Outdoor; I=Indoor. 3/ Data must be suthiitted within the indicated time frame, based on the date of the Guidance tkcument. o 9 ltnth Due Date is April 30, 1986 . o 12 Month Due Date is July 30, 1986 . o 27 Month Due Date is October 30, 1987 . o 39 Month Due Date is October 30, 1988 . o 50 Month Due Date is Sept nber 30, 1989 . 14/ Exposure is not expected to be significant with currently registered use patterns. 5/ Additional data will be required on leaching or adsorptiorVdesorptiofl of dipropetryn degradation products. / Results of terrestrial field dissipation data indicate that greater than 50% of applied dipropetryn would dissipate prior to subsequent application. 7/ Data for nallgraln crops are acceptable; additional data will be required for root crops and leafy vegetables if these are to be rotated. 8/ For crops rotated on treated areas, any one of the following restrictions will apply: a. A tolerance must be obtained for the rotated crop, b. Product label must include a restriction not to plant food and feed crops in dipropetryn-treated fields unless dipropetryn is registered for use on those crops, c. Data must be provided to determine time intervals at which rotated crops planted on dipropetryn—treated fields wil be free of dipropetryn residues. 9/ Data on dipropetryn in combination and tank mixes are not required. 10/ These data requir nents do not apply to current use patterns. 11/ Under the Data CAll-In Notice for Ground Water, photodegradation data were received by the Agency in March 1985 (Accession 257328) and are under review. 28 ------- TABLE A GENERIC DATA RE UI1 ’1ENTS FOR DIPROPETRYN E ta ¶Lk Satis fy Be Submitted Under This Require— Bibliographic FIFRA § 3(c)(2)(B)? t .ta Requir nent 1/ Ccznposltion Use Pattern ment? (Yes, or Partially) No Citation Time Prame for De.ta Submission 3/ §158.135 ToxIcology ACIJIE TES’TING : 81—1 — Acute Oral Toxicity ‘ AI A,B Yes 00O7037 4 No —Pat 81—2 — Acute Dermal Toxicity ‘It AI A,B Yes 00070375 No - Rabbit 81—3 - Acute Inhalation Toxicity TGAI A,B Yes 00070377 No 4/ — Pat 81-4 — Primary Rye Irritation P AI A,B Yes 00034098 No 81—5 — Primary Skin Irritation TGAI A,B Yes 00070375 No 81-6 - Derinal Sensitization ¶ AI A,B Yes 00110376 No 81-7 - Delayed 9X AI A,B 5/ No Neurotoxicity - Hen SUBC}IRONIC TESrING : 82—1 — 90—Day Feeding : — Rodent, and ‘11 AI A,B Yes 00070371 No - Non—rodent (I)g) TGAI A,B Yes 00070372 No 82-2 - 21-Day Derrnal - Rabbit ‘It AI A,B 14/ No 82-3 - 90-Day Dermal - Rabbit ‘It AI A,B 14/ No 29 ------- §158.135 Toxicology — Continued 82—1 — 9O—t y Inhalation: — Rat 82—5 — 9O—t y Neurotoxicity: - Hen —M.qnim i]. CHRONIC TESTING : 83—1 — Chronic Toxicity — 2 species: - Rodent, and - Non-rodent (Dog) 83-2 — c cogenicity - 2 species: — Rat (preferred), and — Mouse (preferred) 83-3 - Toratogenicity - 2 species: — flat — Rabbit 83—14 - Reproduction - Rat 2—generation 1/ Use 2/ 1 .ta Requir nent Canposltion Patterri T BIE A GENERIC DATA RFJ UIRFWRTS FOR DIPROii n YN Does EPA Hav I .ta To Satisfy This Require- ment? (Yes, No or Partially) Must Additional t ta Be Submitted Under Bibliographic Citation FIFRA § 3(c)(2)(B)? Time Frame for t ta ¶LT AI A,B i’io - Yes 6/ 15 Months ¶I’GAI A,B 15/ No ¶L AI A,B 15/ No !Lt AI ¶ AI A,B A,B No No - - Yes Yes 7/8/ 7/8/ 50 50 Months Months ‘I AI A,B No - Yes 7/9/ 50 Months AI A,B No - Yes 7/9/ 50 Months X AI A,B No Yes 10/ 15 Months fl3AI A,B No Yes 10/ 15 Months P3AI A,B No 30 ------- 158.i35 Toxicology - Continued M [ YPAGFNICITY L TI 811—2 — Gene Mutation (Ames I st) 81 1—2 — Structural Chranosanal Aberration 81i-li — Other Genotoxic Erfects SPECIAL TF TflG 85-i - Genera]. Metaboli&n 85-2 - Dermal Penetration 86—i — L imestic Animal Safety 1/ Use 2/ t ta Requiranent Ccinposition Pattern TABLE A GENERIC DATA RE UIREME1 I1’S FOR DI OPETRYN DDes EPA Have De.ta To Satisfy This Require- ment? (Yes, No or Partially) Must Additional t .ta Be Submitted Under Bibliographic Citation FIF’RA § 3(c)(2)(B)? Time Frame for De.ta ¶ AI A,B r - Yes 12/ 9 Months ¶ AI A,B No - Yes 12/ 12 Months ‘It AI A,B No - Yes 12/ 12 Months PAl or PAIRA A,B Yes 13/ 211 Months Choice No thoice 31 ------- TABLE A GENERIC DATA RE7 UIRE74ENI’S FOR DIPROPE RYN Ccinposition: PAl = Pure active ingredient; PAIRA = Pure active ingredient, radio test substances dete mined on a case-by-case basis. The use patterns are coded as follows: A=Terrestri-al, Food Crop; B=Terrestrial, I)=Aquatic, Non-Food; E=Greenhouse, Food Crop; F=Greenhouse, Non-Food; G=Forestry; time frame, based on the date of the labelled; Choice = Cho Non—Food; C=Aqautic, H=Dctnestic Outdoor; Guidance Document.... ice of several Food Crop; I=Iridoor. t ta must be sul:xnitted within the o 9 ? bnth Die t .te is April 30, 1986 o 12 !.bnth Die t te is July 30, 1986 o 15 !tnth Die Lute is October 30, 1986. o 2 4 ! bnth Die Dite is July 30, 1957 o 39 Wnth Die t .te is October 30, 1988 o so Wnth Die t .te is Sept nber 30, 1959. / The acute (11 hour) inhalation toxicity study is considered to be adequate for the acute test. 5/ Dipropetryn is not an organo *iosphate , nor is it known to cause delayed neurotoxicity. / Discolored spleens formed in all dosage levels in the acute inhalation toxicity study indicate that a 90-day inhalation study in the rat is required. 7/ The Agency will require interim reports on the chronic studies. (The registrant should consult the Agency to determine the interim reporting dates for the chronic toxicity studies). 8/ Qwonic toxicity studies in both the rat and in dog are required. 9/ ( icogenicity studies in both the rat and in mouse are required. 10/ Teratology studies in both the rat and rabbit are required. 11/ A two generation reproduction study in the rat is required. 12/ The following mutagenicity data are required: a. In vitro mananalian cell point mutation [ L5178Y (TK), or CHO (HGPRT), or W9 (HGPRT)] tests, b. In vitro cytogenetic damage: both cbrcinosanal aberration and SCE (in CHO cells, or human lymphocytes, or other rodent/human cell lines/strains tests, c • In vitro/in vivo primary hepatocyte repair for UDS testing both in vivo and in vitro exposure of cells to Dipropetryfl, d. In vivo cytogenetics test for chranosomal aberrations using bone marrow preparations of rats, e. Dcinlnant lethal test in rats or mice. 13/ A general metaboliani study of the rat is required. Till The guidelines and uses indicate that these data are not required. 15/ Dita are not required, unless there are indications from other tests or literature which may require data fran this study. S158.135 Toxicology - Continued 1/ 2/ 3/ 32 ------- TABLE A GEN IC DATA R UIRE74E IPS FOR DI} OPE’PRYN Does EPA Have Be Submitted Under tata Th Satisfy FU HA S 3(c)(2)(B)? Data 1iequir nent 1/ Canposition Use 2/ Pattern This Require— ment? (Yes, or Partially) No Bibliographic Citation Time Frame for Data Submission 3/ §158 . 1140 Reentry Protection 132-1 - Foliar Dissipation ‘]EP No 14/ No 132-1 - Soil Dissipation No i/ No 133-3 - Dermal &poeure ‘IEP No li/ 133-14 - Inhalation posure ‘IEP No 14/ §158.1142 Spray Drift 201-1 - Droplet Size Spectrum No ‘s/ No 201-1 - Drift Field Evaluation ‘IEP No 14/ No 1/ Ccmposition: ‘lEP = Typical end-use product. 2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non-Food; C=Aquatic, Food Crop; D=Aquatic, Non—Food; E=Greenhouse, Food Crop; F=Greerthouse, Non-Food; G=Forestry; H=Danestic C*itdoor; 1= Indoor. 3/ Data must be submitted within the Indicated time frame, based on the date of the Guidance Document. ° 27 Month Due Date is not applicable . l / sed on the criteria cited in 140 CPR § 158.1140, re—entry data are not required for dipropetryn. 33 ------- S158.1’45 Wildlife arxl Aquatic Organisms AVIAN AND MANMALIAN TF TING 71—1 - Acute Avian Oral Toxicity 71-2 — Avian Subacute Dietary Toxicity — Upland Game Bird, and — Waterfowl Wild irinal Toxicity Avian Reproduction - Upland Game Bird, and — Waterfowl 71-5 - Simulated Field Testing - Manina.ls, and - Birds — Actual Field Testing - Maxmnals, and - Birds 9 Months 9 Months 1/ Use 2/ Data Requir nent Canposit ion Pattern TABLE A GENERIC DATA RE U R NE S FOR DIPROPETRYN Does EPA Have Data To Satisfy This Require- ment? (Yes, No or Partially) Be Submitted Under Bibliographic FJJ F A § 3(c)(2)(B)? Frame for Data Citation Submission 3/ 71—3 — 71— 4 — TGAI A Partially 00070378 Yes 9 ¶ AI A No Yes AI A I b Yes ‘1t AI A 5/ No mAI A 5/ ¶ AI A 5/ A 5/ A 5/ No 1EP No TEP No TEP A 5/ No ‘IEP A 5/ No 34 ------- - Coidwater Fish Species 72-2 — Acute Ibxicity to Freshwater Invertebrates 72-3 - Acute lbxicity to Eatuarine and Marine Organi - Marine Fish - Mollusk - r1inp 72 — I l - Fish Early Life Stage, and — Aquatic Invertebrate Life—Cycle 72—5 — Fish — Life—Cycle 1/ Use 2/ t .ta Requir iient Canposition Pattern TABLE A GENERIC DATA R UIRH€NTS FOR DIPROPE RYN tbes EPA Have t ta ¶lb Satisfy This Require- ment? (Yes, No or Partially) Bibliographic Must Additional t ta Submitted Under FIFRA § 3(c)(2)(B)? Citation Time Frame for t ta Submission 3/ §158.1115 Wildlife aj j Aquatic Organisms - Continued AQUATIC OfiGANISM PE. TING 72—1 — Freshwater Fish ‘lbxicity - Wannwater Fish Species, I AI A N o6/ - No PEP A Yes 00070379 No ¶ AI A ?b6/ - No PEP A Yes 00070379 No ¶I AI A No - Yes 9Months TE? A No Reserved 4/ AI A No Reserved 4/ ¶ AI A No Reserved 1/ AI A No Reserved 4/ AI A No Reserved 14/ AI A No Reserved 14/ T AI A Reserved LI! 35 ------- TABLE A GENFRIC DATA RE UIRH4ENTS FOR DLPROPF rRYN tbes EPA Have &ist Additional t ta L ta ‘lb Satisfy Fe Sut*nitted Under t ta Requirenent 1/ Canposition Use 2/ Pattern This Require— ment? (Yes, or Partially) I & Bibliographic Citation FIFRA § 3(c)(2)(B)? Time Frame for t .ta SubmissIon 3/ §158.1115 Wildlife arxl Aquatic Organisms - Continued 72—6 — Aquatic Organism TGAI, PAl OR Accixnulation t gradation Product - Crustacean A Reserved LI! - Fish A Reserved LI! - Insect Nym A ND Reserved LI! - Mollusk A ND Reserved LI! 72-7 - Simulated Field Testing - Aquatic Organisms ¶IEP A Reserved 1 1/ — Actual Field Testing -Aquatic Organisms ‘ lEP A Reserved LI! 36 ------- TABLE A GENF IC DATA RE UIRF7IEW1 FOR DIF 0PEPRYN §158.1145 Wildlife and Aquatic Organisms - Continued 1/ Cc*nposition: 1 AI = Technical grade of the active ingredient; PAl = pure active ingredient; PEP = ¶ [ rp1cal end-use product; 2/ The use patterns are coded as follows: A=Terrestrial, Fbod Crop; B=Terrestrial, Non-Food Crop; C=Aquatic, Fkiod Crop; D=Aquatic, }bn-lkod; E=Greenhouse, Fbod Crop; F=Greenhouse, NDn-Fbod; G Forestry; H=Dcinestic Outdoor; I=Iridoor. 3/ Data must be submitted within the indicated time frame, based on the date of the Guidance Document. ° 9 Wnth 1)ie Date is April 30, 1986 14/ Requir nents are pending receipt and review of envirorinental fate data In conjunction with the use on cotton. 5/ The low avian toxicity data and limited use pattern for dipropetryn indicate that data are not required. Li Data for the PEP, (80 WP) will satisfy this requir nent. Any changes in the formulation will require submission of additional data. 37 ------- TABLE A GENBRIC DATA RE UIR IIEI 1rS FOR DIPROPF RYN L es EPA Have Must Additional t .ta L .ta To Satisfy Submitted Under 1/ Use 2/ This Require— Bibliographic FIFRA § 3(c)(2)(B)? t ta Requir nent Canpositlon Pattern ment? (Yes, or Partially) ND Citation Time Frame for t ta Submission 3/ §158.155 Nontarget Insect NOMTARGEYP INSECT TES’PING — POLLINAWRS : 141—1 — Honey bee acute contact toxicity fl3AI A Yes 00066708 No 141—2 — Honey bee — toxicity ‘IEP A li/ No of residues on foliage 141—k - Honey bee subacute (Reserved) 5/ feeding study 141-5 — Field testing for ‘IEP A 14/ No pollinators M)WTARGE P INSECT TESTING - AQUATIC INSECTS : 142—1 — Acute toxicity to (Reserved) 6/ aquatic insects 142—1 — Aquatic Insect (Reserved) 6/ life—cycle study 1142—3 - Simulated or actual (Reserved) 6/ field testing for aquatic insects 1143-1 - NON ARGET INSECT (Reserved) 6/ thru TESTING - PREDA ’ IORS 143—3 AND PARASITES 38 ------- TABLE A GENERIC DATA RE UIRE74EN1”S FOR DIPROPETRYN ft58.155 Nontarget Insects 1/ Canposition: ¶L AI = Technical grade of the active ingredient; PEP = ¶ [ rpical end-use product. 2/ The use patterns are coded as follows: A=Terrestrial, Food Crop; B=Terrestrial, Non—Food; CAquatic, Food Crop: D=Aqautic, Non—Food; E=Greenhouse, Food Crop; F=Greenhouse, Non—Food; G=Forestry; H=Dcmestic Cxitdoor; I=Indoor. 3/ t ta must be submitted within the indicated time frame, based on the date of the Guidance t)cument. ° 9 Wnth tXie t te is not applicable . 14/ No additional data required because the data shows dipropetryn to be relatively non-toxic to bees. 5/ Reserved pending development of test methodology. / Reserved pending Agencys’ decision as to thether data requir nent should be established. 39 ------- TABLE B PRODUCT SPECIFIC DATA RE) UIRE 4EI’.1rS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIPROPE’mYN t ta Must Be Guideline Citation and Test Guidelines Are tO.ta Fbotnote Submitted Within Name of Test Substance Status Required Yes No Number Thne Frames Listed Below 1/ 2 §158.120 Product Ch nistry Product Identity: 61—1 — Product Identity and Disclosure of Ingredients 61—2 — t scription of Beginning Muterlals and Manufacturing Process 61—3 - Discussion of Formation of Impurities Analysis and Certification of Product Ingredients 62—1 — Preliminary Analysis 62—2 — Certification of Limits 62—3 — Analytical Methods to Verify Certified Limit Physical and Ch nica1 Characteristics 63-2 — Color 63-3 — Thysical State 63—a — Qior 63—5 — Melting Point 63—6 — Boiling Foint NP R [ K] [ ii] NP R U [ K] NP CR [ K] c i NP R [ ] [ iii ] NP R [ KJ [ 1J NP R 1=] [ K] NP R [ Ti ] [ K] NP R [ K] [ ii] NP R [ _] [ ] NP R [ _] [ ] 3 3 3 6 12 Menths 12 Menths 12 Mentha 6 2 40 ------- T BIE B PRODUCT SPECIFIC DATA RW IJIRF2’1ERPS PCI MANUFACTURING—USE PRODUCTS COI ITAINING DIPROPE R1N (95% A.1.) E .ta !4ist Be Guideline Citation ard st Guidelines Are t ta Footnote Sulinitted Within Name of Test &tbstance Statu$ Required Number Time Frames Listed Yes No Below 1/ §158.120 Product Ch nistry (Continued) Physical and Chanical Characteristics (Continued) 63—7 — Density, Bulk Density, or Specific Gravity NP R [ TI [ ] 63—12—pH NP R [ Ti [ ] 63-11 - Oxldizirg or ReducirE NP CR [ ] [ TI Action 63—15 - Flammability NP CR [ ] [ Ti 63-16 - &plodabil ity NP R [ X] [ Ti 63-17 - Storage Stability NP R [ J [ Ti 63—18 — Viscosity NP H [ Ti [ J 63-19 — Miscibility NP H [ TI [ ] 63—20 — Corrosion Characteristics NP R [ TJ 1] Other Requiranents: — Sulinittal of s nples NP CR [ TI [ ] 61t— 1 6 T’ bnths 6 Months 6 Months 15 Months 2 2 2 11 5 41 ------- TABLE B PRODUCT SPECIFIC DATA REQUIREMEI’ZTS FOR MANUFACTURING-USE PRODUCTS CONTAINING DIPROPETRYN (95% A.1.) § 158.120 Product Chanistry MP = Manufacturing-use Product; R = Required; CR = Conditionally Required 1/ Data must be submitted within the indicated time frame, based on the date of the Guidance DDcllnent. 2/ 6 Month 1)ie Date is January 30, 1986 . 3/ 12 Month J)ie Date is July 30, 1986 . 7- / 15 Month JXie Date is October 30, 1986 . 5/ This canpound does not require the submittal of samples at the present time. 42 ------- TABLE B PRODUCT SPECIFIC DATA REQUIREMEI\YrS FDR MANUFACTURING-USE PRODUCTS COWPAINING DIPROPETRYN tbes EPA Have Must Additional t ta E ta ‘lb Satisfy Be Submitted Under 1/ This Require— Bibliographic FIFRA § 3(c) (2) (B)? t ta Requlr9nent Canposition ment? (Yes, No Citation Time Frame for L .ta or Partially) Submission 2 §158.135 Toxicology ACtJI’E TESTING 81—i — Acute Oral Toxicity NP Yes 00070374 No — I: .t 81—2 — Acute Dermal Toxicity NP Yes 00070375 No — Rabbit 81—3 - Acute Inhalation Toxicity NP Yes 00070377 No — i: t 81—Is - Primary Rye Irritation MP Yes 00034098 No — Rabbit 81—5 - Primary Derinal Irritation NP Yes 00070375 — Rabbit 81—6 — Der nal Sensitization NP Yes 00110376 No - Guinea Pig §158.135 Toxicology - Continued 1.1 Ccznposition: NP = Manufacturing-use product. 2/ Data must be submitted within the indicated time frame, based on the date of the Guidance Docixnent. 9 Month 1)ie Date is not applicable 43 ------- IV. SUBMISSION OF REVISED LABELING Note : This section applies to end use products only to the extent described in Section I (Regulatory Position and Rationale). Otherwise, the following information pertains exclusively to manufacturing use products. 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-l) and are summarized for products containing this active ingredient as part of this Guidance Document (See Appendix IV-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). 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 labeli . 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)] 44 ------- Item LI. 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 riot appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency. See Appendix IV-l. [ k0 CFR 1 6 2.lO(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. [ 110 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 placed In the body of other text. See Appendix IV—1. [ 110 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 1 4 point 10 point over 30 18 point 12 point 45 ------- Item 7A. CHILD HAZARD WARNING STATEMENT - The statement “Keep Out of Reach of Children” must he located on the front panel above the signal word except where contact with children during distribution or use is unlikely. See Appendix P 1—i. [ Lb CFR 162.l0(h)(l)(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)] 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 l62.1O(h)(1)(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, II, and III. See Appendix IV—1. [ 40 CFR l62.iO(h)(1)(iii)] 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—1. [ 40 CFR 162.10(h)(1)(Iii)] 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)]. 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) (1)] 46 ------- 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. [ i O CFR 162.lO(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 statements. 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 flashpolnt greater than 350°F (177°C). c. A “non—flammable aerosol” is one which meets the following criteria: 1. The flame extension is zero inches; II. There is no flashback; and 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. 47 ------- L . 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 statement8 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 Po8ition 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 4O CFR 162.11(c). You will be notified of the Agency’s classification decision. A. Classification Labeling Requirements If Section I of this Guidance Document indicates that your product has been classified for restricted use, the following label requirements apply: 1. Front panel statement of restricted use classification. 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 4O CFR 162.1O(h)(1)(Iv). 48 ------- 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. B. Compliance Schedules No product with a use classified for restricted use under this Standard may be released for shipment by the registrant or producer after one year from the date of issuance of this Standard, unless such product bears the restricted use classification. All products still in channels of trade after two years from the date of issuance of this Standard must be labeled for restricted use. Item 9B [ There Is no Item 9B]. 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. 49 ------- 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. Item lOB [ There is no Item lOB]. Item lOC. 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— 1 4 to determine the 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 IV—l. [ 4O 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. 50 ------- V. INSTRUCTIONS FOR SUBMISSION A. For Manufacturing Products (MP) containing (dipropetryn) as an 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—i. 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— 14. b. Product Specific Data Report, EPA Form 8580—14 (Appendix 111—1). c. Two copies of any 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. 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 140 CFR 152.80—152.99 (enclosed) for latest requirements, 51 ------- 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 met, notify the Product Manager and the Office of Compliance Monitoring. B. For Manufacturing Use Products containing (dipropetryn) 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 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 (dipropetryn) 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.) 52 ------- 2. Within 6 months from receipt of this document you must submit: a. Confidential Statement of Formula, EPA Form 857O— 4. b. Product—Specific Data Report, EPA Form 8580- 14 (Appendix 111—1). c. Two copies of any required product—specific data. (Refer to Table C). 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. e. Evidence of compliance with data support requirements of FIFRA sec. 3(c)(1)(D), Refer to 140 CFR 152.80—152.99 (enclosed) for latest requirements. 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 (Dipropetryn) 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. Applications and other required information should be submitted to the following address: Robert Taylor Product Manager Registration Division (TS—7670) Office of Pesticide Programs Environmental Protection Agency 401 M St., S.W. Washington, D.C. 20460 Phone No. (703) 557—1800 53 ------- The address for submission to the Office of Compliance Monitoring is: Laboratory Data Integrity Program Office of Compliance Monitoring (EN-3 1 42) Environmental Protection Agency 4O1 M St., S.W. Washington, D.C. 20)460 54 ------- 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’ t 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 Z (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. ii. 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. 55 ------- 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. ( ) 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 l23L 56, the first study would be l23! 56—A; the second, 1231456— B; the 26th, l23 1456—Z; and the 27th, 123 1 456—AA. 56 ------- OFFICE OF PESTICIDE PROGRAMS REGISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the De.ta Base Supporting Registrations Under the Dipropetryn Standard MRID CITATION 00034098 Fink, R.J. (1973) Final Report: Draize Eye Irritation Study——Rab- bits: Project No. 1483—116. (Unpublished study received Jun 8, 1973 under 100—522; prepared by Hazieton Laboratories, Inc., submitted by Ciba—Geigy Corp., Greensboro, N.C.; CDL:000560-B) 00036726 Austin, D.A.; Turner, W.E.; Richarson, C. (1972) GS—16068——Soil Dissipation: Report No. GAAC—72092. (Unpublished study received Dec 15, 1972 under 2F1284; submitted by Ciba—Geigy Corp., Greensboro, N.C.; CDL:092178—C) 00036732 Richardson, C.; Turner, W.E. (1971) Residue Report: Wheat: AG—A No. 2235 1,11. (Unpublished study including AG—A no. 2245 1,11, received Dec 15, 1972 under 2F128 1 4; submitted by Ciba—Geigy Corp., Greensboro, N.C.; CDL:092178-I) 00036740 Rolla, H.M.; Lewis, D. (1971) Determination of GS—16068 in Cotton Forage, Cottonseed, and Cottonseed Fractions by Gas Chromatogra- phy Employing Flame Photometric Detection. Method no. AG—15 1 4 dated Apr 2, 1971. (Unpublished study received Dec 15, 1972 under 2F128 1 1; submitted by Ciba—Geigy Corp., Greensboro, N.C.; CDL: 092178—Q) 00066708 Atkins, E.L., Jr.; Anderson, L.D.; Greywood, E.A. (1969) Effect of Pesticides on Apiculture: Project No. 1499; No. 2177. An- nual rept. (Unpublished study, including submitter suninary, received Aug 8, 1971 under 1(11055; prepared by Univ. of Cali- fornia——Riverside, Dept. of Ehtomology, Div. of Economic Ehto— mology, submitted by Thompson Hayward Ch nical Co., Atlanta, Ga.; CDL:091888—H) 00070371 Fink, R.J.; Voelker, R.W., Jr. (1971) Final Report: 19—week Dietary Administration—-Rats: Project No. 110—145. (Unpublished study received May 1, 1972 under 2G1186; prepared by Hazleton Labora- tories, submitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL: 090998—B) 00070372 Fink, R.J.; Voelker, R.W., Jr. (1971) Final Report: 14—week Dietary Administration--Dogs: Project No. 110—146. (UnpublIshed study received May 1, 1972 under 2G1186; prepared by TRW, Inc., sub- mitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—C) 57 ------- MRID CITATION 00070374 Fink, R. (1970) Final Report: Acute Oral——Rats: Project No. 110— 139. (Unpublished study received May 1, 1972 under 2G1186; pre- pared by ‘NW, Inc., submitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—E) 00070375 Fink, H. (1970) Final Report: Acute Dermal—--Rabbits: Project No. 110—140. (Unpublished study received May 1, 1972 under 2G1186; prepared by TRW, Inc., submitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—F) 00070377 Hidd nen, J.W. (1971) Final Report: Acute Inhalation Exposure—— Rats: Project No. 110—147. (Unpublished study received May 1, 1972 under 2G1186; prepared by TRW, Inc., submitted by Ciba— Geigy Corp., Ardsley, N.Y.; CDL:090998—H) 00070378 Gough, B.J.; Shellenberger, T.E. (1971) Letter sent to Joe Marrus dated May 13, 1971: Acute toxicological evaluations of GS—16068 with bobwhite quail and mallard ducks. (Unpublished study re- ceived May 1, 1972 under 2(11186; prepared by Gulf South Research Institute, submitted by Ciba-Geigy Corp., Ardsley, N.Y.; CDL: 090998—I) 00070379 Heina ann, J.M. (1971) Final Report: Acute Fish Toxicity Study—— Freshwater (Static): Project No. 110—143. (Unpublished study received May 1, 1972 under 2G1186; prepared by TRW, Inc., sub- mitted by Ciba—Geigy Corp., Ardsley, N.Y.; CDL:090998—J) 00103171 Hermes, P.; Knaak, J. (1972) The Uptake of Aged delta—1 1 4C-GS- 16068 and Metabolites in Rotation Wheat and the Degradation of GS—16068 in Soil (Greenhouse): Report No. GAAC-72037. (Unpub- lished study received Jun 10, 1982 under 100—631; submitted by Ciba-Geigy Corp., Greensboro, NC; CDL:070915-H) 001103714 Ciba—Geigy Corp . (1971) Petition for a Negligible Residue Tolerance of 0.1 ppm in Cottonseed for the Herbicide ... GS—16068. (Com- pilation; unpublished study received Oct 13, 1972 under 2F12814; CDL: 091820—B) 00110376 Saunders, H. (1972) Landsteiner Sensitization of GS—16068 Tech., 99.3% GS—16068 in Guinea Pigs: Contract No. 120—1526—52. Final rept. (Unpublished study received Jun 15, 1972 under 2F12814; prepared by Affiliated Medical E iterprise8, Inc., submitted by Ciba Geigy—Corp., Ardsley, NY; CDL:095916—A) 00110378 CIba-Geigy Corp. (1974) Fate of Dipropetryn In the Envirorinent—— Additional Information: Report No. GAAC-74074. (Compilation; unpublished study received Oct 10, 1974 under 2F1284; CDL: 095930—A) 58 ------- OFFICE OF PESTICIDE PROGRAMS REI3ISTRATION STANDARD BIBLIOGRAPHY Citations Considered to be Part of the E ta Base Supporting Registrations Under the Dipropetryn Standard CITATION GSO22 4—OO]. U.S. Departhient of Agriculture (1983) Agricultural Statistics III. Oilseeds, F ts, and Oils: Cottonseed. 112—116. GSO22 1 —OO2 Murray, D.S.; Santelmann, P.W..; Davidson, J.M. (1975) Compa- rative Adsorption, Desorption, arid Mobility of Dipropetryn and Pranetryn in Soil. J. Agric. Food Chem. 23: 578—582. 59 ------- 0MB Approval No. 2000-0468 Appendix 11—3 IEPA REGISTRATION NO. FIFRA SECTION 3(C)(2)(B) SUMMARY SHEET PRODUCT NAME APPUCANTS NAME DATE GUIDANCE DOCUMENT ISSUED With respect to the requirement to submit eneric” data imposed by the FIFRA section 3(C)(2)(B) notice contained in the referenced Guidance Document, I am responding in the following manner 0 1. I Will submit data in a timely manner to satisfy the following requirements. If the test procedures I will use deviate from (or are not specified in) the Registration Guidelines or the Protocols contained in the Reports of Expert Groups to the Chemicals Group, QECO Chemicals Testing Programme, I enclose the protocols that 1 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 tmEPA by: NAME OP OTHER REGISTRANT 03. I encloecompl.t.d ‘Cartifkatlon of Attmupttn Enter IntoenAgreemuitwith Other Registrant.torDeveiopmentof D.ta”with respect to the following data r,qulrsmsnt. 04. I request that you emend my registration by deleting the following uses (this option is not available to applicants for new product.): Os. I request voluntary cancellation of the registratIon of this product. (This option is not available to applicants for new products.) 60 REGISTRANTS AUTHORIZED REPRESENTATIVE SIGNATURE DATE EPA Ponn 5880.1 (10.82) ------- Appendix 11—4 0MB AoDrovaI No. 2000-c1468 (Expires: 12-31-83) CERTIFICATION OF ATTEMPT TO ENTER - - - INTO AN AGREEMENT WITH OTHER REGISTRANTS (To qualify, ce rif’?J 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: GUIDANCE DOCUMENT DATE 1. I am duly ments of a to submit d authorized to Notice under ata concernin represent the following firm(s) who are subject to the require- FIFRA Section 3(c)(2)(B) contained in a Guidance Document g the active ingredient: NAME OF FIRM ACTIVE INGREDIENT EPA COMPANY NUMBER 3. My firm has offered in writing to inter into such an agreement. Copia, of the offers are attached. That offer wee irrevocable and included en offer to be bound by an arbitration decision under FIFRA Section 3(c)(2)(B)(Ili) If final agreement on all terms could not be reached otherwise. This offer wee mad. to the following firm(s) on the following data(s): NAME OP FIRM DATE OF OFFER iFowever, none of those finn(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 will promptly inform me whether my firm must submit data to avoid suspension of its registration(s) under FIFRA Section 3(c)(2HB). (This statement does not apply to applicants for new products.) I give EPA permission to disclose this statement upon request. i . .1 TYPED NAME DATE SIGNATURE ------- Appendix 111—1 PRODUCT SPECIFIC DATA REPORT EPA Registration No. _______________Guidance Document for Dipropetryn Date I — Registration Guideline No. Name of Test Testnot required for my product listed above (check below) I am complying with data requirements by (For EPA Use Odly) Accession Numbers Assigned Citing MRI1 Submit— tin,g Data (At— tached) § 158.20 PRODUCT CHEMISTRY 61—1 Identity of ingredients 61—2 Statement of composition 61—3 Discussion of formation of ingredients 62—1 Preliminary analysis 62—2 Certification of limits 62—3 Analytical methods for enforcement 1 units 63—2 Color 63—3 Physical state 63— 4 Odor 63-5 Melting point 63—6 Boiling point 63—7 Density, bulk— density, or specific_gravity 63—8 Solubi lity 63-9 Vapor pressure 6 3—10 Dissociation constant 6 3—11 Octanol/water partition coefficient 63—12 pH 62 ------- Appendix 111—1 (continued) I Registration Guideline No. Name of Test ¶t st not required for my product listed above (check below) I am complying with data requirements by (For EPA Use ly) Accession Numbers Assigned Citing MRID# SuL nit- ting t ta (At- tached) 63—13 Stability 63—14 Oxidizing/reducing reaction 63—15 Flamnability 63—16 Explodability 63—17 Storage stability 63—18 Viscosity 63—19 Miscibility 6 3—20 Corrosion characteristics 63—21 Dielectric break- down voltage l58.135 ¶L XIC0LOGY 81—1 Acute oral LD—50, rat 81—2 Acute dermal LD-50 81—3 Acute Inhalation, LC—50_rat 81-4 PrImary eye Irritation, rabbit 81-5 PrImary dermal irritation 81—6 Dermal sensitiza- tion 63 ------- Chapter 1——Environmental Protection Agency §162.10 Labeling requirements. (a) General--(l) Contents of the label . Every pesticide product shall bear a label containing the information specified by the Act and the regulations in this Part. The contents of a label must show clearly and prominently the following: (1) The name, brand, or trademark under which the product Is sold as prescribed in paragraph (b) of this section; (ii) The name and address of the producer, registrant, or person for whom produced as prescribed in paragraph (c) of this section; (Iii) The net contents as prescribed In paragraph (d) of this section; (iv) The product registration number as prescribed in paragraph Ce) of this section; (v) The producing establishment number as prescribed in para- graph (f) of this section; (vi) An ingredient statement as prescribed in paragraph (g) of this section; (vii) Warning or precautionary statements as prescribed in paragraph (h) of this section; (viii) The directions for use as prescribed in paragraph (i) of this section; and (lx) The use classification(s) as prescribed in paragraph (j) of this section. (2) Prominence and legibility . (i) All words, statements, graphic representations, designs or other Information required 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, state- ments,, 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 customary conditions of purchase and use. (ii) 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 applied equally to both the English and other-language versions of the labeling. (Li) Placement of Label—-(I) General . The label shall appear on or be aecureI attached to the Immediate container of the 64 ------- pesticide product. For purposes of this Section, and the mis- branding provisions of the Act, “Securely attached” shall mean that a label can reasonably be expected to remain affixed during the foreseeable Conditions and period of use. If the immediate container is enclosed within a wrapper or outside container through which the label cannot be clearly read, the label must also be securely attached to such outside wrapper or container, if it is a part of the package as customarily distributed or sold. (ii) Tank cars and other bulk contalners——(A) Transportation . While a pesticide product is in transit, the appropriate provisions of 49 CFR Parts 170—189, concerning the transportation of hLzardous materials, and specifically those provisions con- cerning the labeling, marking and placarding of hazardous materials and the vehicles carrying them, define the basic Federal require- ments. In addition, when any registered pesticide product is transported in a tank car, tank truck or other mobile or portable bulk container, 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 products 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 discharge control valve. (5) False or misleading statements . Pursuant to section 2(q)(1)(A) 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 pesticida ]. and non—pesticidal 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; (iv) A false or misleading comparison with other pesticides or devices; (v) Any statement directly or indirectly implying that the pesticide or device Is recommended or endorsed by any agency of the Federal Government; (vi) The name of a pesticide which contains two or more principal active ingredIen 5 if the name suggests one or more but not all such principal active ingredients even though the names of the other Ingredien are stated elsewhere in the labeling; (vii) A true statement used in such a way as to give a false or misleading Impression to the purchaser; (viii) Label disclaimers which negate or detract from labeling statements required under the Act and these regulations; 65 ------- (ix) Claims as to the safety of the pesticide or its ingredients, including statements such as “safe,” “nonpoisonous,” “noninjurious,” “harmless” or “nontoxic to humans and pets” with or without such a qualifying phrase as “when used as directed”; and (x) Non-numerical and/or comparative statements on the safety of the product, including but not limited to: (A) “Contains all natural ingredients”; (B) “Among the least toxic chemicals known” (C) “Pollution approved” (6) Final printed labeling . (i) Except as provided in paragraph (a)(6)(ii) of this section, final printed labeling must be submitted and accepted prior to registration. However, final printed labeling need not be submitted until draft label texts have been provisionally 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 microfilm 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: (i) Is false or misleading, or (ii) Has not been approved by the Administrator through registration or supplemental registration as an additional name pursuant to § l62.6(b)C 4). (c) Name and address of producer, registrant, or person for whom produced. An unqualified name and address given on the label shall be considered as the name and address of the producer. If the registrant’s name appears 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 ***,“ “Distributed by or “Sold by to show that the name Is not that of the producer. (d) Net weight or measure of contents . (1) The net weight or measure of content shall be exclusive of wrappers or other materials and shall be the average content unless explicitly 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°C) and shall be expressed in conventional American units of fluid ounces, pints, quarts, and gallons. (3) If the pesticide is solid or semisolid, viscous or pressurized, or is a mixture of liquid and solid, the net content statement shall be in terms of weight expressed as avoirdupois pounds and ounces. (14) In all cases, net content shall be stated In terms of the largest suitable units, i.e., “1 pound 10 ounces” rather than “26 ounces.” 66 ------- (5) In addition to the required units specified, net content may be expressed in metric units. (6) Variation above minimum content or around an average i permissible only to the extent that it represents deviation unavoidable in good manufacturing practice. Variation below a stated minimum is not permitted. In no case shall the average content of the packages in a shipment fall below the stated average content. (e) Product registration number . The registration number assigned to the pesticide product at the time of registration shall appear on the label, preceded by the phrase “EPA Registration No.,” or the phrase “EPA Reg. No.” The registration number shall be set in type of a size and style similar to other print on that part of the label on which It appears and shall run parallel to It. The registration number and the required identifying phrase shall not appear in such a manner as to Suggest or Imply recommendation or endorsement of the product by the Agency. (f) Producing establishments registration number . The producing establishment registration number preceded by the phrase “EPA Est.”, of the final establishment at which the product was produced may appear in any Suitable location on the label or immediate container. It must appear on the wrapper or outside container of the package if the EPA establishment registration number on the immediate container cannot be clearly read through such wrapper or container. (g) Ingredient statement——(1) General . The label of each pesticide product must be a statement which contains the name and percentage by weight of each active ingredient, the total percentage by weight of all inert ingredients; and if the pesticide contains arsenic in any form, a statement of the percentages of total and water—soluble arsenic calculated as elemental arsenic. The active ingredients must be designated by the term “active ingredients” and the inert ingredients by the term “inert ingredients,” or the singular forms of these terms when appropriate. Both terms shall be in the same type size, be aligned to the same margin and be equally prominent. The statement “Inert Ingredients, none” is not required for pesticides which contain 100 percent active ingredients. Unless the Ingredient statement is a complete analysis of the pesticide, the term “analysis” shall not be used as a heading for the ingredient statement. (2) Po jt1onof 1ngredien statement. (I) The Ingredient statement Is normally required on the front panel of the label. If there is an outside container or wrapper through which the ingredient statement cannot be clearly read, the ingredient statement must also appear on such outside container or wrapper. If the size or form of the package makes It impracticable to place the Ingredient statement on the front panel of the label, permission may be granted for the ingredient statement to appear elsewhere. (ii) The text of the ingredient statement must run parallel with other text on the panel on which It appears, and must be clearly distinguishable from and must not be placed In the body of other text. 67 ------- (3) Names to be used in ingredient statement . The name used for each ingredient shall be the accepted common name, if there is one, followed 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 proprietary name be permitted unless such name has been accepted as a common name by the Administrator under the authority of Section 25(c)(6). (Li) Statements of percentag . The percentages of ingredients shall be stated in terms of weight_to_Weight. The sum of per- centages 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 ingredient 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) Accuracy of stated percentages . The percentages given shall be as precise as possible reflecting good manufactUring practice. If there may be unavoidable variation between manu- facturing batches, the value stated for each active ingredient shall be the lowest percentage which may be present. (6) DeterioratiOn . Pesticides which change in chemical composition significantly must meet the following labeling re- quirements: (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 U to the expiration time indicated on the label. (7) Inert ingredients . The Administrator may require the name of any inert ingredient(s ) to be listed in the ingredient statement if he determines that such ingredient(s) may pose a hazard to man or the environment. (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 requirements ncerning content, placement, type size, and prominence are given below. (1) Required front panel statemer’t . With the exception of the child hazard warning statement, the text required on the front panel of the label is determined by the Toxicity Category of the pesticide. The category is assigned on the basis of the highest hazard shown by any of the indicators in the table below: 68 ------- Hazard Indicators I Toxicity categories I I II ill [ iv Oral LP 50 Up to and From 50 thru From 500 thru Greater than Including 500 mg/kg 5000 mg/kg 5000 mg/kg I 50mg/kg Inhalation LC 50 Up to and From .2 thru From 2 thru Greater than I including 2 mg/liter 20 mg/liter 20 mg/liter I .2 mg/liter I I I Dermel LD 50 Up to and From 200 From 2,000 thru Greater than including thru 2000 20,000 20,000 200 mg/kg I I I I 1 I Eye effects I I Corrosive; Cornea? opacity No cornea? opacity; No irritation cornea? opacity I reversible irritation not reversible within 7 days; reversible within 7 days irritation wIthin 7 days persisting for I 7days Skin effects I Corrosive Severe irritation at 72 hours I I Moderate Irritation at 72 hours I Mild or slight irritation at 72hours I I I (i) Human hazard signal word.——(A) Toxicity Category I . All pesticide products meeting the criteria of Toxicity Category I shall bear on the front panel the signal word “Danger.” In addition if the product was assigned to Toxicity Category I on the basis of its oral, inhalation or dermal toxicity (as distinct from skin and eye local effects) 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 word “poison.” (B) Toxicity Category II . All pesticide products meeting the criteria of Toxicity Cate ry II shall bear on the front panel the signal word “Warning.” (C) Toxicily Category III . All pesticide products meeting the criteria of Toxicity Category III shall bear on the front panel the signal word “Caution.” (D) Toxicity Category IV . All pesticide products meeting the criteria of Toxicity Category IV shall bear on the front panel the signal word “Caution.” 69 ------- (E) Use of sig na1 words . Use of any signal word(s) associated with a higher Toxicity Category is not permitted except when the Agency determines that such labeling is necessary to prevent unreasonable adverse effects on man or the environment. In no case shall more than one human hazard signal word appear on the front panel of a label. (ii) Child hazard warning . Every pesticide product label shall bear on the front panel the statement “keep out of reach of children.” Only in cases where the likelihood of contact with children during distribution, marketing, storage or use is demonstrated by the applicant to be extremely remote, or if the nature of the pesticide is such that it is approved for use on infants or small children, may the Administrator waive this requirement. (iii) Statement of practical treatment——(A) Toxicity Category I . A statement of practical treatment (first aid or other) shall appear on the front panel of the label of all pesticides falling into Toxicity Category I on the basis of oral, inhalation or dermal toxicity. The Agency may, however, permit reasonable variations in the placement of the statement of practical treatment is some reference such as “See statement of practical treatment on back panel” appears on the 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)(1)(iil)(A) of this section. The applicant may, however, include such a front panel statement at his option. Statements of practical treatment are, however, required 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 required front panel warning statements shall be grouped together on the label, and shall appear with sufficient prominence relative to other front panel text and graphic material to make them unlikely to be over- looked under customary conditions of purchase and use. The following table shows the minimum type size requirements for the front panel warning statements on various sizes of labels: Size of label front panel in square inches Points Required signal word, all capitals “Keep out of reach of Children” 5andunder. . . . . . Above 5 to 10 . . . . . . . . . . Abovel0tol5 •1S•S••• Abovel5to3O .... .. .. .. Over 30 . . . . . . . . . . . . . 6 10 12 14 18 6 6 8 10 12 70 ------- (F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment. (j) Statement of Use Classification . By October 22, 1976, all pesticide products must bear on their labels a statement of use classification as described in paragraphs (j)(i) and (2) of this section. Any pesticide product for which some uses are classified for general use and others for restricted use shall he separately labeled according to the labeling standards set forth in this subsection, and shall be marketed as separate products with different registration numbers, one bearing directions only for general use(s) and the other bearing directions for restricted 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 provisions of § 162.1O(j)(2). (1) General Use Classification . Pesticide products bearing directions for use(s) classified general shall be labeled with the exact words “General Classification” immediately below the heading “Directions for Use.” And reference to the general classification that suggests or implies that the general utility of the pesticide extends beyond those purposes and uses contained in the Directions for Use will be considered a false or misleading statement 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 classification on the front panel as described below: (i) Front panel statement of restricted 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.lO(h)(1)(iv)), and appearing with sufficient prominence relative to other text and graphic material on the front panel to make it unlikely to be overlooked under customary conditions of purchase and use, the statement “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 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.” If, however, other regulatory restrictions are imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation. (k) Advertising. [ Reserved] [ 4O FR 28268, July 3, 1975; O FR 32329, Aug. 1, 1975; 4O FR 38571, Aug. 21, 1975, as amended at 143 FR 5786, Feb. 9, 1978] 71 ------- (2) Other required warnings and precautionary statements . The warnings and precautionary statements as required below shall appear together on the label under the general heading “Precautionary Statements” and under appropriate subheadings of “Hazard to Humans and Domestic Animals,” “Environmental Hazard” and “Physical or Chemical Hazard.” (i) Hazard to humans and domestic animals . (A) 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. The precautionary paragraph shall be immediately preceded by the appropriate hazard signal word. (B) The following table depicts typical precautionary statements. These statements must be modified or expanded to reflect specific hazards. J Toxicity category Precautionary statements by toxicity category I I [ Oral, inhalation, or dermal toxicity Skin and eye local effects I I . . . Fatal (poisonous) if swallowed [ inhaled or absorbed through skin?. Do not breathe vapor [ dust? or spray mist?. Do not get in eyes, on skin, or on clothing [ Front panel statement of practical treatment required.?. Corrosive, causes aye and skin damage [ or skin irritation?. Do not get in eyes, on skin, or on clothing. Wear goggles or face shield and rubber gloves when handling. Harmful or fatal if swallowed. [ Appropriate first aid statement required.? II . . . May be fatal if swallowed [ inhaled or absorbed through the skin?. Do not breathe vapors [ dust or spray misti. Do not get in eyes, on skin, or on clothing. IAppropriate first aid statements required.?. Causes eye land skin? irritation. Do not get in eyes, on skin, or on clothing. Harmful if swallowed. [ Appropriate first aid statement required.?. II I . . . Harmful if swallowed linhaled or absorbed through the skin?. Avoid breathing vapors [ dust or spray mist?. Avoid contact with skin [ eyes or clothing?. [ Appropriate first aid statement required.?. Avoid contact with skin, eyes or clothing. In case of contact iemediately flush eyes or skin with plenty of water. Get medical attention if irritation persists. 1V . . . [ No precautionary statements required.?. I [ No precautionary statements required.?. — I (ii) Environmental hazards . 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 72 ------- damage. Examples of the hazard statements and the circumstances under which they are required follow: (A) If a pesticide intended for outdoor use contains an active ingredient with a mammalian acute oral LD 50 of 100 or less, the statement “This Pesticide is Toxic to Wildlife” is required. (B) If a pesticide intended for outdoor use contains an active ingredient with a fish acute LC 50 of 1 ppm or less, the statement “This Pesticide is Toxic to Fish” is required. (C) If a pesticide intended for outdoor use contains an active ingredient with an avian acute oral LD 50 of 100 mg/kg or less, or a subacute dietary LC 50 of 500 ppm or less, the statement “This Pesticide is Toxic to Wildlife” is required. (D) If either accident history or field studies demonstrate that use of the 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 application to agricultural crops, forests, or shade trees, or for mosquito abatement treatments, pesticides toxic to pollinating insects must bear appropriate label cautions. (F) For all outdoor uses other than aquatic applications the label must bear the caution “Keep out of lakes, ponds or streams. Do not contaminate water by cleaning of equipment or disposal of wastes.” (iii) Physical or chemical hazards . Warning statements on the flammability or explosive characteristics of the pesticide are required as follows: I I Flash point Required text (A) PRESSURIZED CONTAINERS I Flash point at or below 20°F; If there is a flashback at any valve opening. I Flash point above 20°F and not over 80°F or If the flame extension Is more than 18 In. long at a distance of 6 in. from the flame. All other pressurized containers . . . . . . . . I 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. J Flammable. Contents under pressure. Keep away J from heat, sparks, and open flame. Do not puncture or Incinerate container. Exposure tol 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 tempera— tures above 130°F may cause bursting. I (B) NONPRESSURIZED CONTAINERS At or below 20°F . . . . . . . . . . . . . . . . Above 20°F and not over 80°F . . . . . . . . . . Above 80°F and not over 150°F . . . . . . . . . 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 or open flame. 73 ------- (i) Directions for Use——(1) General requirements——Cl) Adequacy and clarity of directions . 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. (11) Placement of directions for use . Directions 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. Directions for use may appear on printed or graphic matter which accompanies the pesticide provided that: (A) If required by the Agency, such printed or graphic matter is securely attached to each package of the pesticide, or placed within the outside wrapper or bag; (B) The label bears a reference to the directions for use in accompanying leaflets or circulars, such as “See directions In the enclosed circular.” and (C) The Administrator determines that it is not necessary for such directions to appear on the label. (iii) Exceptions to requirement for direction for use——(A ) Detailed directions for use may be omitted from labeling of pesticides which are intended for use only by manufacturers of products other than pesticide products In their regular manu- facturing 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. (2) Adequate information such as technical data sheets or bulletins, Is available to the trade specifying the type of product Involved and its proper use in manufacturing processes; (3) The product will not come into the hands of the general public except after incorporation into finished products; and ( ) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment. (B) Detailed directions for use may be omitted from the labeling of pesticide products for which sale is limited to physicians, veterinarians, or druggists, 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 prevent unreasonable adverse effects on man or the environment; and (3) The product is also a drug and regulated under the provisions of the Federal Food, Drug and Cosmetic Act. (C) Detailed directions for use may be omitted from the labeling of pesticide products which are intended for use only by formulators in preparing pesticides for sale to the public, provided that: (1) There is information readily available to the formulators on the composition, toxicity, methods of use, applicable restrictions or limitations, and effectiveness of the product for pesticide purposes; 74 ------- (2) The label clearly states that the product is intended for use only in manufacturing, formulating, mixing, or repacking for use as a pesticide and specifies the type(s) of pesticide products involved; (3) The product as finally manufactured, formulated, mixed, or repackaged is registered; and c)4) The Administrator determines that such directions are not necessary to prevent unreasonable adverse effects on man or the environment. (2) Contents of Directions for Use . The directions for use shall include the following, under the headings “Directions for (i) The statement of use classification as prescribed in 162.10(j) immediately under the heading “Directions for Use.” (ii) Immediately below the statement of use classification, the statement “It is a violation of Federal law to use this product in a manner inconsistent 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, including Instructions for dilution, if required, and type(s) of applic&tion apparatus or equipment requrled. (vii) The frequency and timing of applications 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 110 CFR Part 170. (Ix) Specific directions concerning the storage and disposal of the pesticide and its container, meeting the requirements of 110 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 warning (See Table in 162.1O(h)(1)(jv),) (x) Any limitations or restrictions on use required to prevent unreasonable adverse effects, such as: (A) Required intervals between application 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] (E) For restricted use pesticides, a statement that the pesticide may be applied under the direct supervision of a certified applicator who is not physically 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 applicator who is physically present. 75 ------- (F) Other pertinent information which the Administrator determines to be necessary for the protection of man and the environment. (j) Statement of Use Classification . By October 22, 1976, all pesticide products must bear on their labels a statement of use classification as described in paragraphs (j)(1) and (2) of this section. Any pesticide product for which some uses are classified for general use and others for restricted use shall be separately labeled according to the labeling standards set forth in this subsection, and shall be marketed as separate products with different registration numbers, one bearing directions only for general use(s) and the other bearing directions for restricted 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 provisions of § 162.1O(j)(2). (1) General Use Classification . Pesticide products bearing directions for use(s) classified general shall be labeled with the exact words “General Classification” immediately below the heading “Directions for Use.” And reference to the general classification that suggests or implies that the general utility of the pesticide extends beyond those purposes and uses contained in the Directions for Use will be considered a false or misleading statement 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 classification on the front panel as described below: (1) Front panel statement of restricted 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.lO(h)(l)(iv)), and appearing with sufficient prominence relative to other text and graphic material on the front panel to make it unlikely to be overlooked under customary conditions of purchase and use, the statement “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 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.” If, however, other regulatory restrictions are imposed, the Administrator will define the appropriate wording for the terms of restriction by regulation. (k) Advertising. [ Reserved] [ L O FR 28268, July 3, 1975; 4O FR 32329, Aug. 1, 1975; IO FR 38571, Aug. 21, 1975, as amended at 143 FR 5786, Feb. 9, 1978] 76 ------- APPENDIX IV-2 LABELING REQUIRE7V1EWI OF THE FIFRA, AS AMENDED ITEM LABEL ELEMENT APPLICABILITY OF REQUIREMENT PLACEMENT ON LABEL COMMENTS REQUIRED PREFERRED 1 Product name All products Front panel Center front panel 2 Cc*npany name and address All products None Bottan 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 Bottcm 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 None Front panel, l irinediately before or following Reg._No. May appear on the container instead of the label. 6A Ingredients statement All products Front panel Iiiinediately following product_name Text must run parallel with other text on the panel. 6B Pounds/gallon statement Liquid products where dosage given as lbs. al/unit area Front panel Directly below 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 Keep (lit of Reach of’ Children (Child hazard warnthg) All products Front panel Above signal word Note type size requirements. 7B Signal word All products Front panel Iriinediately Note type size requirements. below child hazard warning 1! ------- APPENDIX IV-2 (continued) ITEM LABEL ELEMENT APPLICABILITY OF REQUIRE €NT PLACEMENT ON LABEL COMME ’TPS REQUIRED PREFERRED TC Skull & cross— 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 close proximity to signal word 7D Statement of practical treathent All products in Categories I, II, and III Category I: Front panel unless refer- ral statement is used. Others: Grouped with side panel precautionary statements. Front panel for all. 7E Referral statement All products where pre- cautionary labeling appears on other than front panel. Front panel 8 Side/back panel precautionary statements All products None Top or side of back panel preceding directions for_use Must be grouped under the headings in 8A, 83, and 8C; preferably blocked. 8A Hazards to h inans and dcinestic animals All products in Categories I, II, and III None Same as above Must be preceded by appropriate signal word. 8B F virorinental hazards All products None Same as above ivirorrnental hazards include bee caution where applicable. 78 ------- APPENDIX IV-2 (continued) ITE 4 - LABEL ELE 4E??T APPLICABILITY OF 1JtR Et fP RFJ UIRED PBEP RRED COWEW2S None Same as above BC Thysicel or chemical hazards - All pressurized products, others with flash points under 150°F center Preferably Includes a statement of the terms Ôf 9A Restricted block All restricted products ¶Ibp of front panel Ijyinediately blocked restriction. The ‘ rds “F FSThICTED USE PESTICIDE” must be same type size as signal_word. 9C Misuse 8tatement All products . following heading of” directions for use In the ) mnediatelY 1OA Reentry statement AU choUnesterase inhibitors - directions for use In the after misuse statement ] miediately tist be set apart and clearly distin- lOC Storage and disposal block All products directions for use None before specific directions for use or at the end of directions for use None guishable fran fran other directions for use. W r be in metric as l1 as U.S. units 1OD Directions for use All products 79 ------- 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 CONTAINERS 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. 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. 80 ------- Appendix IV- 1 4 STORAGE AND DISPOSAL INSTRUCTIONS FOR PESTICIDES 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.” The STORAGE AND DISPOSAL heading must appear in the minimum type size listed below: Required type size Size of label for the heading front panel In STORAGE AND DISPOSAL square Inches (all capitals) 10 and under . . . . . . . . . . . . . . .6 point Above 10 to 15 . . . . . . . . . . . . . .8 point Above 15 to 30 . . . . . . . . . . . . . 10 point Over 30 . . . . . . . . . . . . . . . . . 12 p o In t Storage and disposal Instructions must be set apart and clearly distinguishable from other directions for use. Blocking storage and disposal statements with a solid line is suggested as a means of increasing their prominence. A. 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. 81 ------- Appendix IV—4 (continued) 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. ( eneral 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. B. Pesticide Disposal Instructions : 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, ‘To not contaminate water, food, or feed by storage or disposal.” 2. Except those products intended solely for domestic use, the labels of all products that contain active ingredients appearing on the “Acutely Hazardous” Commercial Pesticide Products List (RCRA “E” List) at the end of 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 Inhala- tion toxicity must bear the following pesticide disposal statement: “Pesticide wastes are acutely hazardous. Improper dis- posal 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.” The labels of all products, except those intended for domestic use, containing active or inert ingredients that appear on the “Toxic” Commercial Pesticide Products List (RCRA “F” List) at the end of this appendix or presently meet any of the criteria in Subpart C, 40 CFR 261 for a hazardous waste must bear the following pesticide disposal statement: 82 ------- Appendix IV- 1 4 (continued) “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.” Labels for all other products, except those intended for domestic use, must bear the following pesticide disposal statement: “Wastes resulting from the use of this product may be disposed of on site or at an approved waste disposal facility.” 3. Products intended for domestic use only must bear the following disposal statement: “Securely wrap original container in several layers of newspaper and discard in trash •“ C. Container Disposal Instructions The label of each product must bear container disposal instructions appropriate to the type of container. 1. All products intended for domestic use must bear one of the following container disposal statements: Container Type Statement Non-aerosol products (bottles, cans, Jars) Do not reuse container (bottle, can, Jar). Rinse thoroughly before discarding In trash. Non-aerosol products (bags) Do not reuse bag. Discard bag in trash. Aerosol products Replace cap and discard containers in trash. Do not incinerate or puncture. 83 ------- Appendix IV— 1 4 (continued) 2. The labels for all other products must bear container disposal instructions, based on container type, listed below: Container Type Statement !/ Manufacturer may replace this phrase with one indicating whether and how fiber drum may be reused. Metal containers (non—aerosol) Triple rinse (or equivalent). Then offer for recycling or reconditioning, or puncture and dispose of in a sanitary landfill, 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!, 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) 84 ------- Appendix IV- 2 1 (continued) Pesticides that are hazardous wastes under 140 CFR 261.33(e) and (f) when discarded. “ Acutely Hazardous” Commercial Pesticides (RCRA “E” List) Active Ingredients, (no inerts) : Acrolein Aidicarb Aid r in Allyl alcohol Aluminum phosphide Lt —Aminopyrid me Arsenic acid Arsenic pentoxide Arsenic trioxide Calcium cyanide Carbr’ n disulfide p-Ohio roanil me Cyanides (soluble cyanide salts, not specified elsewere) Cyanogen chloride 2-Cyclohexyl-14 , 6-dinitrophenol Die 1 d r in 0,0-Diethyl S— [ 2-ethylthio)ethyl] phosphorodithioate (disulfoton, Di-Syston) 0,0-Diethyl 0—pyrazinyl phosphorothioate (Zinophos) Dimethoate 0,0-Dimethyl 0-p-nitrophenyl phosphorothioate (methyl parathion) 1 4,6—Dinitro—o—cresol and salts 14, 6-Dinitro-o—cyclohexylphenol 2,14 Dinitrophenol Dinoseb Endosulfan Endothall Endrin F am phu r Fluoroacetamide Heptachlor Hexanethyl tetraphosphate Hydrocyanic acid Hydrogen cyanide Met horny 1 alpha-Naphthylthiourea (ANTU) Nicotine and salts Octamethylpyrophosphoramide (OMPA, schradan) Parathion 85 ------- Appendix IV- 1 (continued) “ Acutely Hazardous” Commercial Pesticides (RCRA “E” List) Active Ingredients continued : Phenylmercuric acetate (PMA) Phorate Potassium cyanide Propargyl alcohol Sodium azide Sodium cyanide Sodium fluoroacetate Strychnine and salts O,O,C,O—Tetraethyl dithiopyrophosphate (sulfotepp) Tetraethyl pyrophosphate Thallium sulfate Thiofanox Toxaphene Warfarin Zinc phosphide 86 ------- Appendix IV-L (continued) “ Toxic” Commercial Pesticide Products (RCRA “F” List) Active Ingredients : Acetone Acrylonitrile Am i t role Benzene Bis (2—ethyihexyl )pthalate Cacodylic acid Carbon tetrachioride Chioral (hydrate) Chiordane (technical) Chlorobenzene —Chloro—m—cresol Oh 10 ro form o—Chlorophenol Lt Ch1oro o to1uidine hydrochloride C reosote Cresylic acid Cyclohexane (kepone, chiordecone) l,2—Dibromo—3—chloropropane (DBCP) Dibutyl phthalate S—3,3-(Dichloroallyl dilsopropyithiocarbamate (diallate, Avadex) o—Dlch lorobenzene p—Dich lorobenzene Dichiorodifluoromethane (Freon 12 ) 3,5—Dlchloro—N—(l,1—dlrnethyl—2--propyny l) benzamlde (pronamide,Kerb) Dichioro diphenyl dichioroethane (DDD) Dichioro diphenyl trichioroethane (DDT) Dichiorethyl ether 2, 1 —Dich1orophenoxyacetjc, esters and salts (2,L _D) 1, 2—flichioropropane 1 ,3—Dichioropropane (Telone) Dimethyl phthalate Ethyl acetate Ethyl 14,14’ —dichlorobenzilate (chlorobenzilate) Ethylene dibromide (EDB) Ethylene dichioride Ethylene oxide Formaldehyde Furfural Hexachlorobenzene Hexachiorocyclopentadlene Hexachloroethane Hydrofluoric acid 87 ------- Appendix IV— 1 4 (continued) “ Toxic” Commercial Pesticide Products (RCRA “F” List) Active Ingredients : Isobutyl alcohol Lead acetate Lindane Maleic hydrazide Mercury Methyl alcohol Methyl bromide Methyl chloride 2,2’—Methylenebis (3,14,6-trichlorophenol) (hexachiorophene) Methylene chloride Methyl ethyl ketone )4—Methyl—2—pefltaflOfle (methyl isobutyl ketone) Naphthalene Nitrobenzene p—Nitrophenol Pentachioroethane PentachloronitrobeflZefle (PCNB) Pentaclorophenol Phenol Phosphorodithioic acid, 0,0—diethyl, methyl ester Propylene dichioride Pyridine Resorcinol Saf role Selehium disulfide Silvex 1,2, 14,5—TetrachlorobeflZefle 1,1, 2, 2—Tetrachioroethafle Tetrachioroethylene 2,3, 4, 6—Tetrachiorophenol Thiram Toluene 1,1 , 1—Trichioroethane Trichioroethylefle Trichloromonofluoromethane (Freon il®) 2,4, 5—Trichloropheflol 2 ,14 , 6—Trichiorophenol 2,14,5—TrichiorophefloXyacetiC acid (2,LI,5—T) Xylene 88 ------- Appendix IV-L (continued) “ Toxic” Commercial Pesticide Products (RCRA “F” List) Inert Ingredients : Acetone Formaldehyde Acetonitrile Formic acid Acetophenone Isobutyl alcohol Acrylic acid Meleic anhydride Aniline Methyl alcohol (methanol) Benzene Methyl ethyl ketone Ch].orobenzene Methyl methacrylate Chloroform Naphthalene Cyclohexane Saccharin and salts Cyclohexanone Thiourea Dichiorodifluoromethane (Freon 12 ) Toluene Diethyl phthalate 1,1, l—Trichloroethane Dimethylamlne 1,1, 2—Trichioroethane Dimethyl phthalate Trichiorofluoromethane (Freon li®) l, 1 —Dioxane Vinyl chloride Ethylene oxide Xylene 89 aOT JI I? 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