CHAPTER 2 - HOW TO APPLY FOR REGISTRATION OF A PESTICIDE A. GENERAL INFORMATION The Agency separates pesticides into two general categories, conventional chemical pesticides and 2) biochemical and microbial pesticides. Refer to Chapter 3 for information on registration requirements for biochemicals and microbial pesticides. B. TYPES OF PESTICIDE APPLICATIONS The Agency categorizes pesticide applications as follows: 1. New chemical - this is an application for registration of a product containing a new pesticide (active ingredient) that is not an active ingredient in a product currently registered with the Agency (40 CFR 152.114). 2. New use - this is an application for registration of a use for an active ingredient(s), or formulation type, not currently included in the directions for use of any product that contains such active ingredient(s) or formulation type. New uses are defined in 40 CFR 152.3(p) as follows: a. Any proposed use pattern (i.e., one that would result in pesticide residues in food or feed commodities) that would require the establishment of a tolerance, an increase in an established tolerance, or the exemption from the requirement of a tolerance, or food additive regulation under section 408 or 409 of the Federal Food, Drug and Cosmetic Act (refer to Chapter 7 for a discussion of tolerances), b. Any aquatic, terrestrial, outdoor, or forestry use pattern, if no product containing the active ingredient is currently registered for that use pattern, or c. Any additional use pattern that would result in a significant increase in the level of exposure, or a change in the route of exposure of man or other organisms to the active ingredient. 3. "Me-too" - a "me-too" is an application for registration of a pesticide product that is substantially similar or identical in its uses and formulation to products that are currently registered. A more detailed discussion of a "me- too" product is contained in Chapter 6, D., Question 1. IMPORTANT NOTE: If you increase the dosage rate of your product over that which is currently registered, change a pre-harvest interval (PHI) or make other changes which might have an effect on the pesticide residues in food or feed commodities or exposure to nontarget organisms, your application is no longer considered to be a "me-too" application. Changes in the inerts in your formulation, either by varying the percent or by using inerts not registered in a similar product, may also be a determining factor as to whether your product is considered to be a "me- too". If you include an unregistered source of the active ingredient(s) in your product, the product may no longer be considered a "me-too" product. C. CONTENTS OF APPLICATION Your application for registration of a pesticide must include the following information, as applicable. For a more detailed discussion of this information refer to 40 CFR section 152.50, Contents of Application. 1. Application Form - An original Application for Pesticide Registration form (EPA Form 8570-1) must be completed and submitted with each application for registration. Detailed instructions on completing the application form are provided on the back of each form. It is important that you read these instructions and that the information you provide is complete and accurate. Be certain that the form has a red number in the upper right hand corner since only EPA original forms (forms with a red number in the upper right hand corner of the document) are acceptable and also be certain that you sign your application form. Identity of the Applicant Name - An applicant must identify himself. An applicant not residing in the United States must also designate a U.S. agent (see below), to act on his behalf on all registration, and if necessary, tolerance matters. Address of record - An applicant must provide an address in the United States for correspondence purposes. The U.S. address provided will be considered the applicant's address of record and the Agency will send certain notices (i.e., those imposing legal requirements) and correspondence concerning the application and any subsequent registration information to that address. It is the responsibility of the applicant or registrant to ensure that the Agency has a current and accurate address. IMPORTANT NOTE: You must keep the Agency informed of your current name and address of record. If the Agency's good faith attempts to contact you are not successful, the Agency will issue in the Federal Register a notice of intent to cancel ALL OF YOUR REGISTERED PRODUCTS under FIFRA section 6(b) (refer to 40 CFR 152.122). You should notify the Information Services Branch (ISB), Program Management and Support Division (PMSD), of any changes in your company name or address. Refer to Chapter 18 for the address. Authorized agent - You may designate a person residing in the United States to act as your agent. If you wish to designate an agent, you must send the Agency a letter stating the name and U.S. address of the agent. You must also notify the Agency if you change your designated agent. You may terminate a designated agent at any time by notifying the Agency in writing. Authorized Agent notifications are treated by the Agency the same as company name and address changes. Correspondence concerning authorized agents should therefore be sent to the Information Services Branch (ISB), Program Management and Support Division (PMSD). 2. Confidential Statement of Formula - A Confidential Statement of Formula (EPA Form 8570-4) must be completed and submitted with each application for registration. Detailed instructions for completing the form and providing acceptable information are provided on the back of the form. Additional information can be found in 40 CFR 158.150-190. You should also refer to 40 CFR 158.108 for additional discussion of the product chemistry requirements. IMPORTANT NOTE: The Confidential Statement of Formula (CSF) is generally considered to be a document that contains Confidential Business Information (CBI) and should not be transmitted over FAX machines unless the sender wants to clearly waive his or her CBI rights and states this on the CSF. 3. Draft Labeling - The product label is the written, printed, or graphic material on, or attached to, your pesticide product. The term "labeling" includes all labels and all other written, printed or graphic material which accompanies your product when sold or distributed, or to which reference is made on the product's label or in literature accompanying the product. Five copies of your proposed draft labeling must be submitted with your application. The draft labeling may be typed or otherwise printed, but must be legible, reproducible and on 8 1/2 x 11 inch paper. If bilingual labeling is not required by the Agency and you wish to add such text to your labeling, you may do so after notification to the Agency. Implicit in a notification of bilingual labeling is an assurance that the bilingual text is an accurate translation of the English labeling text. The Agency recognizes that translating English language terms to Spanish may be a problem because Spanish terms from different parts of the Spanish speaking world may have a whole different meaning. Registrants should use the appropriate Spanish translation for their labeling. Note that the Agency believes the Spanish language translations to be used for "Caution", "Warning", and "Danger" are "Precaucion", "Advertencia", and "Peligro", respectively. Detailed information on labeling requirements, such as the ingredients statement, warnings and precautionary statements, and directions for use can be found in 40 CFR 156.10. Guidance for the content and format of labels and labeling is provided in Appendix 2-1 and Figures 1 and 2, which are located after section I. of this Chapter. 4. Data - Three copies of all applicable data required to support the registration of your product must be submitted with your application. The data must be formatted in accordance with the requirements which are provided in 40 CFR Part 158.32-34, and in PR Notice 86-5. You should also refer to Chapter 12 of this manual, for additional guidance on how to format your data submission. At the very minimum, most formulated products which are substantially similar or identical to other registered products, will be required to submit the product specific chemistry data, which are discussed in detail in 40 CFR Part 158.150-190. If your product is not substantially similar or identical to another registered product, you will also be required to submit, at the minimum, the acute toxicity data on your product. The toxicology data requirements can be found in 40 CFR Part 158.340. Additional information can be found in the Pesticide Assessment Guidelines, Subdivision F. Refer to 40 CFR 158.108 for a discussion of the Pesticide Assessment Guidelines and their relationship to the data requirements. In addition, the source of the active ingredient you use to formulate your product must be registered, otherwise you must provide, at a minimum, product chemistry data on the technical grade of the active ingredient as well as on your formulated product. It should be noted that although efficacy data (product performance data) are not routinely required to be submitted for most insecticide, fungicide or herbicide products, it is the registrant's responsibility to ascertain through testing that the product performs in accordance with its labeling claims. EPA may require the submission of the product performance data on which claims are based. IMPORTANT NOTE: Efficacy data (product performance data) are routinely required to be submitted to support products that control pests of public health significance, i. e. products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice. Otherwise, efficacy data may be required to be submitted on a case by case basis. (Note: applicant are required to prove to themselves that the product is efficacious when used as directed but efficacy data need only be submitted as described above.) Refer to 40 CFR Part 158.640 for product performance data requirements. IMPORTANT NOTE: If you submit data that are not properly formatted in accordance with PR Notice 86-5, or submit fewer than the required number of copies, your application will likely be rejected and returned. 5. FIFRA section 3(c)(1)(F) [formerly 3(c)(1)(D)] data compensation requirements -Each applicant applying for registration of a pesticide must comply with the data compensation procedures under FIFRA section 3(c)(1)(F). Refer to 40 CFR 158, especially the tables in 158.190 - 158.740, to determine what data might be required for your particular product. No application for registration can be approved until you comply with these requirements. Detailed procedures are contained in 40 CFR 152.80 - 152.99. A discussion of these requirements and the applicable forms are discussed in Chapter 6 of this manual. You should refer to Chapter 6 to determine how you may wish to comply with the data compensation requirements and what forms would be applicable for the method you choose. 6. Data waivers - A waiver of data requirements occurs when the data appear to be required by 40 CFR Part 158 but for some scientific reason in that specific instance it is not necessary for the data to be generated. There is often confusion as to what a data waiver is or is not. The regulations may say that certain data are not applicable to a category of products such as in some of the footnoted items in the Data Requirement Tables in 40 CFR 158. Inapplicability of data is not a waiver of data. Or, new data may not be necessary because there are other data that can be substituted to fulfill the data requirement, e. g., an applicant might submit studies done by the paint industry, or threshold levels determined by NIOSH/OSHA to fulfil the requirement for inhalation toxicity data for her/his product. In this situation data are needed and appropriate, but are already available from an existing source. Using data from such a source is not a waiver of data. On the other hand, waivers from the data requirements specified in 40 CFR 158, as applicable to a category of products, may be requested for an individual product in that category, if that product has special features which make the development of such data inappropriate. For example, some products may have unusual physical, chemical, or biological properties or atypical use patterns which would make particular data requirements inappropriate, either because it would not be possible to generate the required data or because the data would not be useful in the Agency's evaluation of the risks or benefits of the product. In these cases the Agency will waive data requirements it finds are inappropriate, but will ensure that sufficient data are available to make the determinations required by the applicable statutory standards. The Agency will also, on a case-by-case basis, consider waiving specific data requirements when an applicant demonstrates in writing that the specific data are not necessary for the Agency to address the particular concern in question. The waiver request should be accompanied by all of the pertinent information or references to which the applicant refers. The applicant may, under 40 CFR 152.91, demonstrate compliance for a data requirement by: a) claiming that a waiver previously granted by the Agency also applies to a data requirement for her/his product. To document this claim, the applicant must provide a reference to the Agency record that describes the previously granted waiver, such as an Agency list of waivers or an applicable Registration Standard/ Registration Eligibility Document and must explain why that waiver should apply to his product. b) requesting and being granted a new waiver to satisfy the data requirement. An applicant who plans to request a data waiver should discuss his plans with the EPA Product Manager responsible for his product before developing and submitting extensive support information for the request. To request a data waiver, the applicant must submit a written request to the appropriate Product Manager. The waiver request must specifically identify the data requirement for which a waiver is requested, and must provide specific information, relative to each requirement for the compound in question, explaining why the applicant thinks the data requirement(s) should be waived, describe any unsuccessful attempts to generate the required data, furnish any other information which the applicant believes would support the request, and when appropriate, suggest alternative means of obtaining data to address the concern which underlies the data requirement. For example, to support a waiver for inhalation toxicity data, an applicant might submit information showing that the product is of a nature that precludes the potential for exposure. The Agency needs scientifically sound information in order to make a decisions on specific data waiver requests. Simply stating that a product is ubiquitous in nature, or is Generally Recognized as Safe (GRAS) is insufficient. The specific waiver must allow the Agency to determine if the kind and levels of exposure resulting from the proposed pattern of use is analogous to the submitted information. The Agency will review each data waiver request and inform the applicant in writing of its decision. In addition, for decisions that could apply to more than a specific product, the Agency may choose to send a notice to all registrants or to publish a notice in the FEDERAL REGISTER announcing its decision. An Agency decision denying a written request to waive a data requirement shall constitute final Agency action for purposes of FIFRA section 16(a). Agency decisions on data waiver requests are available to the public at the Office of Pesticide Programs' Docket Reading Room, Room 1132, Crystal Mall Building #2, 1921 Jefferson Davis Highway, Arlington, VA 22202 from 8:00 a.m. to 4 p.m., Monday through Friday, except legal holidays. 7. Certification relating to child-resistant packaging - If your product meets the criteria which requires child- resistant packaging (refer to 40 CFR 157.20 - 157.39), you must submit a certification that the packaging that will be used for the product meets the child-resistant packaging standards in 40 CFR 157.32. 8. Restricted use classification - The Agency has classified some or all of the uses of certain pesticides as a "Restricted Use Pesticide". A restricted use classification generally restricts the product "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" [40 CFR 156.10(j)(2)]. The criteria used for determining whether your particular product requires the restricted use classification can be found in 40 CFR 152.170. A listing of those pesticides that the Agency has classified for restricted use by regulation can be found in 40 CFR 152.175. Refer to 40 CFR 152.160 - 171 for a detailed discussion on the classification of pesticides. A listing of all Restricted Use Pesticides is available from the Pesticide Information Network. See Chapter 16 for further information. 9. Compliance With Reregistration Documents a. Registration Standards - Prior to the FIFRA Amendments in 1988, the reregistration program issued documents called Registration Standards. These Registration Standards provided information similar to that described under "b" below. Until the existing Registration Standards are updated by Reregistration Eligibility Documents, the application is to be prepared by using the Registration Standard as instructed under "b". b. Reregistration Eligibility Documents - FIFRA was amended in 1988 and added section 4 which provides for the reregistration of registered pesticides. As a result, the Agency has developed a program for the review of the pesticide active ingredient, the data supporting the registration of products containing the active ingredient, and their uses. Upon completion of this review, a Reregistration Eligibility Document (RED) is issued. The RED sets forth the Agency's decision on whether products containing a pesticide are eligible for reregistration. It assesses the acceptability of existing tolerances, and describes the need for additional data or information. Following issuance of the RED, procedures will be implemented for reregistration of end-use formulations. Product specific data and revised labeling will be called in to the Agency and evaluated during this period. If a RED and an accompanying data call-in (DCI) have been issued for the active ingredient(s) contained in your product, your application for registration must address any data, data compensation, and labeling, or other requirements that are applicable to your product. D. COMPLETENESS OF APPLICATION You are responsible for the accuracy and completeness of all information submitted in connection with your application. The procedures for submitting a complete application for registration are discussed below and detailed information is contained in 40 CFR Subpart C, section 152.40 - 152.55, entitled Registration Procedures. A separate application for registration must be made for each pesticide product. A pesticide product registration pertains to a manufacturing use product or end-use formulation with only one set of active ingredients. Variations in active ingredients or their percentage in the manufacturing use or end- use formulations are considered separate products and require separate registrations. However, EPA may approve a basic formulation and one or more alternate formulations where only the inert ingredients vary in a single product registration. In addition specific types of formulated products require separate registrations (i.e., liquids, aerosols, baits, dusts, etc.). Your application will be screened upon receipt to determine if it is complete. If it is determined to be complete, the application will be processed and placed in review. Incomplete applications will be returned without further processing. A complete application must contain the following information which consists of two parts, one containing administrative information and the other containing data. As you read the information below, you should refer to Appendix 2-2, which is located after section H. of this Chapter, for a schematic representation of the various documents that are required to be submitted. ADMINISTRATIVE PORTION OF APPLICATION: The Administrative portion of your application consists of the following documentation: 1. A properly completed Application for Pesticide Registration/Amendment (EPA Form 8570-1, Revised 9- 88) 2. A properly completed Confidential Statement of Formula (EPA Form 8570-4, Revised 2-85) 3. Five legible, reproducible copies of the proposed draft labeling for your product on 8 1/2" x 11" paper. 4. FIFRA section 3(c)(1)(F) data compensation forms, as applicable. [FootNote: The food, Agriculture, Conservation and Trade Act of 1990 (FACTA) and the 1991 Amendments of FACTS made a number of amendments fo FIFRA. One of those amendments was to redesignate Section 3(c)(1)(D) as Section (3)(c)(1)(F). Therefore, when citing the data compensation section of FIFRA you should now refer to 3(c)(1)(F) and not 3(c)(1)(D).] Normally the following two data compensation forms are required to be submitted with a typical "me-too" application for registration. a. A properly completed Certification with Respect to Citation of Data [EPA Form 8570- 29 (7-86)], and b. A properly completed Formulator's Exemption Statement [EPA Form 8570-27 (10- 86)]. You should refer to Chapter 6 of this manual for a detailed discussion of the data compensation requirements and how they may apply to your application. IMPORTANT NOTE: Only one complete set of the documents in the administrative portion of your application is required. This information should not be bound. IMPORTANT NOTE: The submission of obsolete editions of the required forms is unacceptable, and will result in your application being rejected. Unsigned forms are unacceptable and will cause your application to be rejected. DATA PORTION OF APPLICATION: The data portion of your application must address the following types of data. 1. Product specific chemistry data - usually required for all "me-too" applications. 2. Acute toxicity data - not required to be submitted under the Cite-all Method of data compensation, if your product is "substantially similar" or "identical" to another currently registered product. Required under the Selective Method of data compensation unless valid studies applicable to your product are cited. Refer to footnote in Appendix 2-1. 3. Efficacy data - are routinely required to be submitted to support products that control pests of public health significance, i. e. products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice. Otherwise, efficacy data may be required to be submitted on a case-by- case basis. (Note: applicants and registrants are required to ensure through testing that the product is efficacious when used as directed but efficacy data need only be submitted as described above.) 4. Generic data -these data pertain to the active ingredient (as opposed to the total pesticide product). These data must be submitted or cited for new uses or products not formulated with a registered product and new chemicals. IMPORTANT NOTE: Your application will be rejected if the required three copies of the data are not properly bound and formatted in accordance with PR Notice 86-5. Provide a Data Matrix Chart of the data and corresponding EPA identifier numbers if the Selective Method of data support is used. See page 6-8 and Appendix 6-2. E. INCOMPLETE APPLICATIONS If you submit an incomplete application, the processing of your application will not begin until the deficiencies are corrected. The application will be returned to you, with the deficiencies identified for correction. IMPORTANT NOTE: New Chemical/First Food Use Screening Process. You should be aware of PR Notice 86-4, issued April 15, 1986, which announced the Agency policy regarding incomplete applications for registration of pesticides under section 3 of FIFRA. Under that policy EPA generally will no longer accept or process any incomplete application received after May 1, 1986, for: 1) registration of a pesticide product containing a new active ingredient or 2) registration of the first food use of a previously registered active ingredient and 3) to petitions to establish tolerances that accompany applications for registration of the food uses of such chemicals. PR NOTICE 86-4 REQUIREMENTS FOR APPLICANTS. Each application to which PR Notice 86-4 applies must be accompanied by a transmittal document which: 1) identifies the application as being for approval of a new chemical or the first food use of a previously registered chemical; 2) lists the studies and other materials required to support the application in accordance with 40 CFR parts 152, 156, 158, and 162; 3) states that all such required studies and other materials are submitted with or cited in the application; 4) states which requirement each study or other material satisfies; 5) lists the location in the application where each item may be found; and 6) is signed by the authorized representative of the applicant. Waivers of specific data requirements may be requested in the application, as provided by 40 CFR 158.45, but must be accompanied by all information necessary to justify a waiver. EPA PROCEDURES UNDER PR NOTICE 86-4. 1) Screening of applications: Before commencing full evaluation of an application and supporting materials, the Agency will conduct a two-stage screen of the application. In the first stage the Agency will determine if 1) all items listed in the transmittal document are included, 2) all material is legible and written in English, and 3) all studies and other materials required by regulations (40 CFR 152, 156, 158, and 162) are included. Applications found to be incomplete will not be processed further, but will be returned to the applicant. [FootNote: Applications found during the screening process to be incomplete or to include unacceptable studies will not be processed further. The applicant will receive a statement of the reason(s) for the rejection and instructions to arrange the retrieval of the application within 10 days. If the applicant does not retrieve the application, the Agency will send the material to the Federal Records Center for permanent strorage. The Agency may, however, decide to retain the studies included in an incomplete application for review to aid in the evaluation of other existing or proposed registrations.] If the application submission passes the first-stage screen, it will be further screened by scientific reviewers to determine that any included studies appear to be acceptable with regard to experimental design and conduct (see 40 CFR 158.80). If any study is found to be unacceptable in this second-stage screen the Agency will take no further action on the application. The application will be returned to the applicant. [FootNote: Applications found during the screening process to be incomplete or to include unacceptable studies will not be processed further. The applicant will receive a statement of the reason(s) for the rejection and instructions to arrange the retrieval of the application within 10 days. If the applicant does not retrieve the application, the Agency will send the material to the Federal Records Center for permanent strorage. The Agency may, however, decide to retain the studies included in an incomplete application for review to aid in the evaluation of other existing or proposed registrations.] If a rejected application is resubmitted it will again be screened as previously described. Agency review time-tables: The Agency is committed to perform both screening processes within 15 working days of receipt of the application by OPP's mailroom. Applicants will be notified by telephone when an application has been deemed complete and acceptable for the purposes of detailed review. The Agency is committed to completing its review of the studies contained in applications that pass the screen within the following timeframes: new chemical applications for food uses or non-food uses that require chronic toxicity data, 375 days; new chemical applications for non-food uses that do not require chronic toxicity data, 250 days; applications for a first food use product, from 205 to 375 days, depending upon the amount of data that must be submitted and reviewed. In most cases, this review will enable the Agency to decide whether each study meets the guideline requirements and whether there is sufficient information to conclude that the proposed uses will not result in unreasonable adverse effects. If the Agency finds that additional information is required to resolve issues that arise during its review, more time will be needed to reach a regulatory decision. F. EXPEDITED REVIEW OF "ME-TOO" APPLICATIONS FOR REGISTRATION Section 3(c)(3)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act requires EPA to expedite the review of "me- too" applications for registration, i. e., products that are "substantially similar" or "identical" to other EPA registered pesticide products. In addition, EPA is required to (1) notify the applicant within 45 days of receipt of the application whether or not the application is complete and, if it is found to be incomplete, deny it, (2) notify the applicant within 90 days after receiving a complete application if the application has been granted or denied and (3) if the application is denied, notify the applicant in writing of the specific reasons for the denial. 1. Applications Which Qualify for Expedited Review "Me-too" applications for registration qualify for expedited registration under section 3(c)(3)(B) of FIFRA. A "me-too" application for registration is one that is "substantially similar" or "identical" to another EPA registered product, not only in the active and inert ingredients, but also bears the same use pattern(s) and essentially the same use directions as another currently registered product. You must provide the EPA Registration Number of the currently registered product you believe is "substantially similar" or "identical" to your product. A "me-too" application for registration requires only minimal supporting product chemistry, acute toxicity and, if applicable, efficacy data. 2. Applications Which DO NOT Qualify for Expedited Review EPA will not expedite applications for registration of products for which the formulation or labeling vary from that of currently registered products, i. e., it is not "substantially similar" or "identical" to another EPA registered product. Examples include, but are not limited to, products that contain (a) inerts ingredients that do not currently exist in any other pesticide formulation; (b) significant changes in the percentage of active ingredient; (c) new formulation types; (d) directions for controlling new pests; (e) directions for new dosage rates; (f) directions for different frequency and timing of applications; (g) directions for use in different geographical locations other than those previously registered; and (h) directions for use on new sites and for new methods of application for that active ingredient or ingredients. These types of changes may increase the risk to humans or the environment through increased exposure and therefore require more data to assess the risks. EPA will not expedite applications for "me-too technical- grade" or "me-too manufacturing-use" products, since extensive product chemistry and often toxicology data are required for these types of applications. These data are more complex and require more time to review then the data associated with the "me-too" applications for registration described above in item 1. 3. How to Submit Your "Me-too" Application for Expedited Review If you believe your "me-too" application for registration qualifies for expedited (fast track) review, you should print "EXPEDITE" at the top of the application above the words "Application for Pesticide Registration" (EPA Form 8570-1). [FootNote: An explanation of the 45/90-day expedited review process (fast track) and detailed procedures for processing applications under it may be found in PR Notice 89-2.] All applications must be on the EPA Form 8570-1 which bears a red unique identification number in the upper right hand corner. You must also identify in Section II of the application form, the EPA Registration Number and name of the product to which you believe your product is "substantially similar" or "identical". You must also enclose two self-addressed, stick-on labels for EPA to use in responding to your application. If you are resubmitting in response to an objection letter from EPA, your resubmission (on EPA Form 8570-1) must be marked "Expedite-Resubmission" at the top of the application form and must include a copy of EPA's objection letter. GUIDELINE FOR DETERMINING AN APPLICATION'S ELIGIBILITY FOR FAST TRACK REVIEW: A new end-use product application qualifies for fast track review only if the proposed pesticide is identical or substantially similar to a currently registered pesticide or differs only in ways that would not significantly increase the risk of unreasonable adverse effects on the environment, cited by EPA Reg. No., in your application. EXAMPLES OF END USE ME-TOO APPLICATIONS THAT QUALIFY FOR FAST TRACK REVIEW: - Applicant references similar, registered pesticide product and submits Product Chemistry. - Applicant references similar, registered pesticide product and submits Product Chemistry, bridging acutes (not more than 2 studies) and confirmatory efficacy to confirm similarity. - Applicant is repackaging a registered product. EXAMPLES OF END USE ME-TOO APPLICATIONS THAT DO NOT QUALIFY FOR FAST TRACK REVIEW: - Applicant references similar, registered pesticide product and submits Product Chemistry, and required Efficacy for Specific Formulation purposes. - Applicant asserts similarity but does not reference pesticide product. Submits Product Chemistry. - Applicant references a similar pesticide product and submits Product Chemistry and required nitrosamine data for Specific Formulation. - Applicant does not reference a pesticide product. Submits Product Chemistry and required nitrosamine data for Specific Formulation. - Applicant does not reference a pesticide product. Submits Product Chemistry and the full battery of Acutes. - Applicant references a similar registered pesticide product. Submits Product Chemistry, the full battery of Acutes, and required efficacy data. [Note: Applications For New Manufacturing Use Products, including Technical Grade Products, are excluded from fast track review by FIFRA Section 3(c)(3)(B)(i)(I).] You must direct your application or resubmission to the appropriate address listed below and identify the type of application in the address by using the abbreviation shown below: (APPL) - for an application for new product registration [FootNote: OPP uses Distribution Codes to facilitate the delivery of mail, data submissions, etc., within the program. "APPL" is the OPP Distribution code for an application for new product registration. If you are submitting an appli- cation for something other than an application for new product registration, refer to the Distribution Codes for OPP set forth in Chapter 18 of this manual or to PR Notice 91-5, Attachment 1. If you are unable to determine which code is appropriate for your submission, omit the code.] By Mail: Document Processing Desk (Appl) Office of Pesticide Programs (H7504C) U.S. Environmental Protection Agency 401 M Street, S.W. Washington, D.C. 20460-0001 By courier or hand delivery: Office of Pesticide Programs Document Processing Desk (Appl) Room 258, Crystal Mall 2 1921 Jefferson Davis Highway Arlington, VA 22202 4. Agency Screening of Your Application for Expedited Review A Front End Processing Staff (FEPS) unit has been formed to screen and process your application for registration. The FEPS will provide an initial screen of your application to determine if (1) it qualifies for an expedited review in accordance with section 3(c)(3)(B), and (2) it is a complete application, i. e., it contains the administrative information and applicable data identified in section D of this chapter, and (3) the data are in compliance with the data formatting requirements of PR Notice 86-5. If your application passes the initial screening process, it will be assigned a file symbol and sent to the appropriate Product Manager Team for further processing. The Product Manager Team will screen the application again, to determine that it is indeed a "me-too" application which qualifies for the expedited review. In addition, the Product Manager Team will determine if the efficacy data requirements, which are routinely required to be submitted to support products that control pests of public health significance, i. e., products to control bacteria, viruses, mosquitoes, ticks, roaches, fleas, rats and mice, have been addressed. If the application is determined to be complete, the application will be placed in review. If it is determined to be incomplete, the entire application will be returned to the FEPS. The FEPS will notify you that the Product Manager Team has further screened your application and determined that your application has been determined to be incomplete. Your application will be returned. 5. Timeframes for Agency Response to Expedited "Me-too" Applications a. 45 Day Response - Within 45 days of receipt of your application, EPA will notify you whether your application is complete or incomplete. If your application is determined to be complete, you will receive a letter acknowledging receipt and the file symbol assigned to your application. If your application is determined to be incomplete, you will be informed in writing of what is needed to make the application complete. For an incomplete application, the entire application will normally be returned to the address of record or to the address on the self- addressed label, if provided. (It is your responsibility for notifying EPA of any changes in name or address, or of a change in designated agent, if any, to avoid correspondence being sent to the wrong address). If an application is too large to be easily mailed, EPA will contact you by telephone and request that the application be picked up within 10 days. If the application is not picked up within 10 days it may be destroyed. IMPORTANT NOTE: If it is determined that your application does not qualify for an expedited review, you will be notified and the application will be processed according to the regular review procedures. Resubmissions in response to an Agency denial letter will initiate a new 45/90 day response cycle. b. 90 Day Response - Within 90 days of receipt of your application which qualifies for expedited review, EPA will conduct a full review of the application and notify you of the results of the review. If the initial application was complete, the reviews are favorable and no additional information is required, registration will be granted. If additional information is necessary in order to complete our review, the application will be denied and you will be notified in writing of the deficiencies. IMPORTANT NOTE: Although FIFRA requires EPA to review applications for expedited registration within 90 days of receipt, this turnaround time may not be met immediately due to a continuing backlog of applications. However, EPA is increasing automated resources, developing instructional aids (this manual is one of these aids) for applicants and making necessary procedural changes in order to eliminate the backlog and to meet the 90 day response time for expedited reviews as soon as possible. G. WHERE TO SUBMIT YOUR APPLICATION See section F.3. of this Chapter for the address to be used in submitting your application for expedited review to the Agency. Refer to Chapter 18 of this manual for the address to be used in submitting all other applications to the Agency. H. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions, or require additional information concerning your application for registration, contact the Product Manager assigned the pesticide in your product. A listing of Product Managers and a sampling of the pesticides they are responsible for may be found in Chapter 18. If you have any questions concerning the status of your "Me- too" Application for Registration within the 45 day timeframe for the Agency's notifying you of whether the application is complete or has been denied, you should contact the Front End Processing Staff, Registration Support Branch. Refer to Chapter 18 for the telephone number. If you have questions of a general nature that do not pertain to any specific pesticide or pertain to a new pesticide active ingredient for which you have not made an application, contact the Deputy Branch Chief or the Branch Chief's office for the type of pesticide (i.e., insecticide, fungicide, herbicide, antimicrobial, etc.) for which you have a question. A listing of the various Deputy Branch Chiefs and Branch Chiefs can be found in Chapter 18. I. REFERENCES CITED IN CHAPTER 2 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 152 - Pesticide registration and classification procedures Part 153 - Registration policies and interpretations Part 156 - Labeling requirements for pesticides and devices Part 157 - Packaging requirements for pesticides and devices Part 158 - Data requirements for registration Part 180 - Tolerances and exemptions from tolerances for pesticide chemicals in or on raw agricultural commodities 2. Federal Food, Drug and Cosmetic Act, as amended Section 408 - Tolerances for pesticide chemicals in or on raw agricultural commodities Section 409 - Food additives 3. Federal Insecticide, Fungicide and Rodenticide Act, as amended, October 1988 Section 3 - Registration of pesticides Section 4 - Reregistration of pesticides 4. PR Notice 86-4 - Submission of Incomplete Applications for Registration of Pesticides Under Section 3 of FIFRA. Issued by the Registration Division, Office of Pesticide Programs, EPA, April 15, 1986. 5. PR Notice 86-5 - Standard Format for data submitted under the Federal Insecticide, Fungicide and Rodenticide Act, and certain provisions of the Federal Food, Drug and Cosmetic Act. Issued by the Registration Division, Office of Pesticide Programs, EPA, July 29, 1986. 6. PR Notice 89-2 - Expedited Review of Applications for Registration or Amended Registration. Issued by the Registration Division, Office of Pesticide Programs, EPA, June 6, 1989. 7. PR Notice 91-5 - Instructions for Transmitting Information to the Office of Pesticide Programs. Issued by the Program Management and Support Division, Office of Pesticide Programs, EPA, September 6, 1991. 7. Listing of Restricted Use Pesticides, compiled by the Registration Support Branch, Registration Division, Office of Pesticide Programs, EPA. 8. Listing of Registration Standards and Reregistration Eligibility Documents (REDs), compiled by the Document Management Section, Information Services Branch, Program Management Support Division. 9. Food, Agriculture, Conservation, and Trade Act of 1990, November 28, 1990 Subtitle H - Pesticides; Sections 1491 through 1499 10. Food, Agriculture, Conservation, and Trade Act Amendments of 1991, December 13, 1991 Section 1006 - Amendments to FIFRA and Related Provisions APPENDIX 2-1 PESTICIDE LABELING REQUIREMENTS EPA's requirements and policies for pesticide labels and labeling are specified in 40 CFR 156.10, Pesticide Regulatory (PR) Notices and various decision documents for specific chemicals (i.e., Special Reviews, Registration Standards, Reregistration Eligibility Documents, etc.). Following are general and specific guidelines for the contents of labels and labeling. Sample formats are shown in Figures 1 and 2. General Guidance Labels and labeling must accurately communicate important precautions and instructions to the user so that each product is effective without causing unreasonable adverse effects to humans or the environment. In addition, the label is a legal, enforceable document. Therefore, labels and labeling must meet the following general criteria: o Comply with EPA's regulatory requirements. o Be clear and understandable to the user under normal conditions. o Provide accurate precautions and directions that protect the user, other humans and the environment. o Contain no false or misleading statements or implied Federal Government endorsements. o Clearly distinguish between language that is mandatory and enforceable statements and language that is only advisory and cannot be enforced. Specific Guidance Following is a summary of the specific items that must appear on the label and/or labeling. The location of these items is shown in Figures 1 and 2, which are sample formats for restricted use and unclassified products, respectively. 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. [40 CFR 156.10(b)] Item 2. COMPANY NAME AND ADDRESS - The name and address of the producer, registrant or person for whom the product is produced are required on the label and should be located at the bottom of the front panel or at the end of the label text. [40 CFR 156.10(c)] 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. Net contents must be expressed in conventional American units of fluid ounces, pints, quarts, and gallons. The net contents must also be expressed in the largest suitable unit, e. g., "1 pound 10 ounces" rather than "26 ounces." In addition to American units, net contents may be expressed in metric units. [40 CFR 156.10(d)] Item 4. EPA REGISTRATION NUMBER - The registration number assigned to the pesticide product must appear on the label, preceded by the phrase "EPA Registration No." or "EPA Reg. No." The registration number must be set in type of a size and style similar to other print on that part of the label on which it appears and must run parallel to it. The registration number and the required identifying phrase must not appear in such a manner as to suggest or imply recommendation or endorsement of the product by the Agency. [40 CFR 156.10(e)] Item 5. EPA ESTABLISHMENT NUMBER - The EPA establishment number, preceded by the phrase "EPA Est." is the final establishment 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. [40 CFR 156.10(f)] Item 6A. INGREDIENTS STATEMENT - An ingredients statement is required, preferably on the front panel immediately below the product name. 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, with a total of 100%. It 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 Figures 1 and 2. [40 CFR 156.10(g)] Item 6B. POUNDS PER GALLON STATEMENT - For liquid agricultural formulations, the pounds per gallon of active ingredient must be indicated on the label. Item 6C. NAMES TO BE USED IN INGREDIENT STATEMENT - The acceptable common name, if there is one, shall be used, followed by the chemical name. If no common name has been established, the chemical name alone shall be used. Item 6D. INERT INGREDIENTS RECLASSIFIED AS ACTIVE INGREDIENTS - If EPA has reclassified chemicals from inert ingredient status to active ingredient status, registrants of affected products must change the ingredient statement accordingly . If such pesticides have food uses, tolerances may be required to be established if the percentage of the pesticide in the product formulation exceeds the limits set in the exemption from tolerance under 40 CFR 180.1001. (Note: If EPA has reclassified chemicals from active ingredient status to inert ingredient status, registrants of affected products must also change the ingredient statement accordingly.) [40 CFR 153.125] Item 6E. NOMINAL CONCENTRATION - The amount of active ingredient declared in the ingredient statement must be the nominal concentration of the product as defined in 40 CFR 158.153(i) and described in PR Notice 91-2. Item 7. WARNINGS AND PRECAUTIONARY STATEMENTS - Front panel precautionary statements must be grouped together on the label (preferably within a block outline) so as to appear with sufficient prominence relative to other front panel text and graphic material to make then unlikely to be over-looked under customary conditions of purchase and use. The table below shows the minimum type size requirements for various size labels. Size of Label on Signal Word "Keep Out of Reach Front Panel Minimum Type Size of Children" in Square Inches All Capitals Minimum Type Size 5 and under 6 point 6 point above 5 to 10 10 point 6 point above 10 to 15 12 point 8 point above 15 to 30 14 point 10 point over 30 18 point 12 point Item 7A. CHILD HAZARD WARNING STATEMENT - The statement "Keep Out of Reach of Children" must be located on the front panel above the signal word except where contact with children during distribution, use or storage is unlikely, or in the instances where the pesticide has been approved for use on infants or small children. [40 CFR 156.10(h)(1)(ii)] Item 7B. SIGNAL WORD - The signal word (DANGER, WARNING, or CAUTION) is required on the front panel immediately below the child hazard warning statement. [40 CFR 156.10(h)(1)(i)] The signal word is also required on the side panel under Hazards to Humans and Domestic animals (see Item 8A). 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. [40 CFR 156.10(h)(1)(i)(A)] 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. [40 CFR 156.10(h)(1)(iii)] Item 7E. REFERRAL STATEMENT - The statement "see Side (or Back) Panel for Additional Precautionary Statements" is required on the front panel of all products unless all required precautionary statements appear on the front panel. [40 CFR 156.10(h)(1) (iii)] [FootNote: During the reregistration review process the Agency may require that the statement of practical Treatment include toxicity due to skin and eye effects in addition to oral, dermal or inhalation effects. The Agency may, in the course of that review process, also require that the Statement of Practical Treatment appear on the front panel of the label. These and other labeling requirements resulting from the reregistration review process will aupersede the instructions in this manual.] 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 sections must be headed by the appropriate subheadings (8A, 8B and 8C). [40 CFR 156.10(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. These statements must be preceded by the signal word. [40 CFR 156.10(h)(2)(i)] Item 8B. ENVIRONMENTAL HAZARD - Where a hazard exists to non- target organisms excluding humans and domestic animals, precautionary statements are required stating the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage. [40 CFR 156.10(h)(2)(ii)] Item 8C. PHYSICAL OR CHEMICAL HAZARD - FLAMMABILITY - Precautionary statements relating to flammability of a product are required to appear on the label if it meets the criteria in 40 CFR 156.10(h)(2)(iii). The requirement is based on the results of required flashpoint determinations and flame extension tests 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. 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). If your product has been classified for restricted use, then these requirements apply: 1. All uses restricted. The following statements should be placed in a box (block outline) at the top of the front panel of the label and labeling: 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 the human hazard signal word [see table in 40 CFR 156.10(h)(1)(iv)]. (The signal word is determined by the product's toxicity category, just as it is for general use products.) No statements of any kind may appear above this RUP statement. b. The reason for the restricted use classification should appear below the RUP statement. Statements may be used in combination if there is more than one reason for the RUP classification. Some examples of restricted use reason statements are listed below: 1. "Acute inhalation toxicity" 2. "Acute dermal toxicity" 3. "Acute oral toxicity" 4. "Acute eye irritation" 5. "Toxic to fish and aquatic organisms" 6. "Toxic to birds" 7. "Toxic to wildlife" 8. "Potential for groundwater contamination" 9. for teratogenicity: "Has been shown to cause birth defects in laboratory animals" 10. for oncogenicity: "The use of this product may be hazardous to your health. This product contains (Chemical Name), which has been determined to cause tumors in laboratory animals" 11. "Due to the complexity of application and use directions" c. A summary statement of the terms of restriction must appear directly below this reason statement on the front panel. 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 some uses are classified for restricted use and some are not, several courses of action are available: a. If you wish to include both restricted and unrestricted uses on a single product label, you may do so, but you must label the product for restricted use. b. You may delete all restricted uses from your label and submit draft labeling bearing only unrestricted uses. (Of course you lose the uses you delete, but you may sell an unrestricted product.) 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 registration, each containing all forms and necessary labels. Both applications should be submitted simultaneously. Note that the products will be assigned separate registration numbers upon registration. Item 9B. MISUSE STATEMENT - All products must bear the misuse statement, "It is a violation of Federal law to use this product in a manner inconsistent with its labeling." This statement appears at the beginning of the directions for use, directly beneath the heading of that section. Item 10A. REENTRY STATEMENT - If a restricted entry interval (REI) 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 10B. 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 PR Notices 83-3 and 84-1 to determine the storage and disposal instructions appropriate for your product(s). Item 10C. 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. The directions for use must include the following: (a) the site(s) of application, i. e., crops, animals, areas, or objects to be treated; (b) identifi- cation of the target pest(s) associated with each site; (c) the dosage rate associated with each site and pest; (d) the method of application, including instructions for dilution, if required, and type(s) of application apparatus or equipment required; (e) the frequency and timing of applications necessary to obtain effective results without causing unreasonable adverse effects on the environment; and (f) any limitations or restrictions on use required to prevent unreasonable adverse effects, i. e., required intervals between application and harvest of food or feed crops, rotational crop restrictions, warnings as required against use in or adjacent to certain areas or on certain crops, animals or objects. [40 CFR 156.10(i)(2)] COLLATERAL LABELING Bulletins, leaflets, circulars, brochures, data sheets, flyers or other written, printed or graphic matter which is referred to on the label or which is to accompany the product are called collateral labeling. Such labeling may not bear claims or representations that substantially differ from those accepted in connection with registration of the product. Collateral labeling must be submitted along with the application for registration. USE OF BILINGUAL LABELING If bilingual labeling is not required by the Agency and you wish to add such text to your labeling, you may do so after notification to the Agency. Implicit in a notification of bilingual labeling is an assurance that the bilingual text is an accurate translation of the English labeling text. The Agency recognizes that translating English language terms to Spanish may be a problem because Spanish terms from different parts of the Spanish speaking world may have a whole different meaning. Registrants should use the appropriate Spanish translation for their labeling. Note that the Agency believes the Spanish language translations to be used for "Caution", "Warning", and "Danger" are "Precaucion", "Advertencia", and "Peligro", respectively. MATERIAL SAFETY DATA SHEETS (MSDS) Material Safety Data Sheets (MSDS) are Hazard Communication Standards required by the U. S. Department of Labor's Occupational Safety and Health Administration under 29 CFR 1910.1200. They are required for chemicals, other than pesticides, and serve much like the label on a pesticide product in conveying safety information about the chemical. FIFRA Section 2(p)(2)(A) defines labeling as "all labels and all other written, printed, or graphic matter accompanying the pesticide or device at any time." Including an MSDS in or on a carton of pesticide product would meet this definition. However, EPA does not intend to review Material Safety Data Sheets as labeling at this time but will instead permit them to accompany a pesticide product under the provisions of 40 CFR 152.46(b)(3) which permits registrants to change a product's non-mandatory labeling or packaging, including additions or changes required by other Federal statutes or regulations, without notification to or approval by the EPA, providing such labeling is consistent with the labeling requirements set forth in 40 CFR Part 156. Registrants should note that it is possible that information on an MSDS could conflict with a pesticide label (e.g., protective clothing recommendations or first aid directions) and that they should therefore assure that the MSDS and the approved pesticide labeling are not in conflict. EPA may find a conflict to be a misbranding violation under FIFRA section 12(a)(1)(E) as defined in FIFRA section 2(q). NOTE: Three figures, Figures 1, 2 and 3, have been omitted here due to the required use of graphics display. These figures were labeled in the original document as follows: Figure 1. Sample Format for Restricted Use Product Label -- Products With High Acute Toxicity (Toxicity Category I) Figure 2. Sample Format for Restricted Use Product Label -- Products With Other Than High Acute Toxicity (Toxicity Categories II, III and IV) Figure 3. Sample Format for Unrestricted Use Product Label. APPENDIX 2-2 A COMPLETE APPLICATION FOR REGISTRATION OF A TYPICAL "ME-TOO" PRODUCT REQUIRES THE FOLLOWING DOCUMENTS A. ADMINISTRATIVE PORTION OF APPLICATION: (DO NOT BIND DOCUMENTS OR PAGES TOGETHER) +-----------+ | | Application for Pesticide Registration | o------ (EPA Form 8570-1) | | | | | |----+ | | | Statement identifying the "substantially | | o---- similar" or "identical" product |DOCUMENT 1 | | +-----------+ | | |----+ Confidential Statement of Formula | | | | | o---- (EPA Form 8570-4) |DOCUMENT 2 | | +-----------+ | | |----+ | | |+ | | o-------- Draft labeling (5 copies) |DOCUMENT 3 | |||+ +-----------+ ||||+ | |||³| | |||||----+ Certification with | ||||| o------- Respect to Citation of |DOCUMENT 4 ||||| | Data (EPA Form 8570-29) +-----------+|||| | +-----------+||| | +-----------+|| |----+ +-----------+| | | +-----------+ | | |DOCUMENT 5 | |-- - +-----------+ | | Data Matrix Formulator's | | o------- Chart Exemption Statement ------------o | | (EPA Form 8570-27) | | (Required under |DOCUMENT 6 | | the selective +-----------+ method of | | support ONLY) |DOCUMENT 7 | - - - - - - B. DATA PORTION OF APPLICATION: (FORMATTED AS DESCRIBED IN PR NOTICE 86-5) +-----------+ | |+ | ||+ Product Specific Chemistry | o----------- Data (3 copies) | ||| | |||-- - | ||| |- Product Specific Acute Toxicity | ||| o------------ Data (3 copies) * |DOCUMENT 1 ||| | | | +-----------+|| | | | (Required under the selective method +-----------+| | | | of support ONLY) +-----------+ | | |----+ | | | | |+ |DOCUMENT 2 | | | ||+ |_ _ _ _ _ _| | | o-------- Efficacy Data (3 copies) if | | | ||| required (routinely |_ _ _ _ _ _| | ||| required for products that |_ _ _ _ _ _| ||| control pests of public | ||| health significance) |DOCUMENT 3 ||| +-----------+|| +-----------+| +-----------+ ---------------------------------------------------------------- * Under the selective method of support these data requirements may be addressed by either submitting the actual data, or by referencing EPA's Master Record Identification (MRID) number on the Data Matrix Chart.