GENERAL INFORMATION ON APPLYING FOR REGISTRATION OF PESTICIDES IN THE UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF PESTICIDE PROGRAMS REGISTRATION DIVISION SECOND EDITION -- AUGUST 1992 PREFACE This instruction manual, which is divided into 18 chapters, is intended to provide a general overview and guidance for persons seeking to register a pesticide in the United States. Every attempt has been made to make the information contained in this Instruction Manual accurate and current, however, changes in the Federal pesticide law [Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)], regulations, policies and requirements are an ongoing process. Thus, changes may occur without you being notified directly, and will take precedence over the information contained herein. In this respect, changes made in this second edition of the instruction manual make the previous edition obsolete. Information in the first edition should be disregarded. If you wish to obtain more specific details on the laws and regulations governing the use and sale of pesticides in the United States, this information is contained in the Federal Insecticide, Fungicide and Rodenticide Act, as amended, and in the Code of Federal Regulations (40 CFR Parts 150-189). Refer to Chapter 16 for information on the source of these documents. Applications and registration actions will be measured against actual regulatory requirements for sufficiency. Therefore, this manual should be considered as a summary offering general guidance and not as a substitute for consulting applicable regulations and law. This second edition of the instruction manual has been developed in an effort to provide applicants and registrants with the most recent general guidance on registering pesticides in the U.S. Draft copies of the second edition of the manual were sent to a number of people for review and comment. Numerous suggestions were received and have been incorporated in the final document. We wish to thank all of those who responded with their comments and suggestions. In addition to a general updating of the original instruction manual we have added the following entries: 1. A glossary of terms (following chapter 18); 2. A general index (following the glossary at the end of the manual; 3. A paragraph on clearance of adjuvants (chapter 1); 4. A paragraph on clearance of inerts for products labeled for food crops (chapter 1); 5. A clarification of "fast track" products (chapters 2, 4); 6. A section on Reregistration Eligibility Documents (REDs) (chapter 2); 7. A section on Data Waivers (chapter 2); 8. Reference to the Food, Agriculture, Conservation, and Trace Act (FACTA) of 1990 and the 1991 Amendments of FACTA making a number of amendments to FIFRA, one of which was the redesignation of FIFRA Section 3(c)(1)(D) as Section 3(c)(1)(F) (chapters 2, 4, 6, ); 9. A labeling appendix, with a sample label format for restricted and non-restricted use products (chapter 2). 10. A section on final printed labeling (chapter 4); 11. A section on "certification of compliance" statements under "How to Submit Notifications." (chapter 4); 12. Reference to PR Notice 91-8 regarding third party data producers (chapter 6); 13. A note indicating that the data gap option may not be available to certain applicants (chapter 6); 14. A section on data compensation charges/payment disputes (chapter 6); 15. The addition of a question on repackaged technical grade products under the "Questions and Answers" section of Chapter 6 (question 3, chapter 6); 16. The addition of a question on how long data submitters have to respond to an offer to pay under the "Questions and Answers" section of Chapter 6 (question 11, chapter 6); 17. The addition of a question on whether an applicant is subject to the data requirements of Agency issued Data Call-Ins, Registration Standards, and Reregistration Eligibility Documents as well as the requirements of CFR 158 under the Questions and Answers" section of Chapter 6 (question 18, chapter 6); 18. A note stating that a temporary tolerance associated with an Experimental Use Permit is not required if the treated commodity is to be destroyed or consumed only by experimental animals (chapter 7); 19. The discussion of tolerance fees in Chapter 9 has been moved to Chapter 7; 20. Chapter 9 ("What Fees Are Required For Registration and Tolerance Petition Activities) has been redesignated as the "new" Chapter 8 and chapter 8 (How to Apply For An Experimental use Permit) has been redesignated as "new" Chapter 9; 21. Inclusion of an "Experimental Use Permit Summary Worksheet" to new chapter 9; 22. A note warning against the transmittal of confidential business over FAX machines (chapter 12); 23. Addition of a section on "Grounds for EPA Disapproval of State Registrations (chapter 14); 24. The addition of sections on "Shipping (Transportation) of Pesticides" and "Nonindigenous and Genetically Engineered Microbial Products" regulatory contacts to Chapter 15; and 25. The addition of a facsimile directory to Chapter 18. We hope the changes we've made to the original manual will provide you, the reader, with more information and make the manual easier for you to use. We welcome any comments, suggestions for changes, or additions that you believe will make this manual more useful. Your comments should be addressed to Mr. Herbert S. Harrison, Chief, or Mr. Harvey L. Warnick, Deputy Chief, Insecticide-Rodenticide Branch, Registration Division, Office of Pesticide Programs. Their addresses and phone numbers can be found in Chapter 18 of this manual. TABLE OF CONTENTS OF THIS INSTRUCTION MANUAL CHAPTER 1 - WHO MUST APPLY FOR REGISTRATION This chapter contains information on who must file, and the various types of registrations for which you may wish to apply. CHAPTER 2 - HOW TO APPLY FOR REGISTRATION OF A CONVENTIONAL PESTICIDE This chapter contains information on how to submit an application to register a pesticide that you wish to distribute or sell, and the associated data and labeling requirements. CHAPTER 3 - CONSIDERATIONS FOR REGISTRATION OF A BIOCHEMICAL OR MICROBIAL PESTICIDE This chapter contains information on applying for registration of biochemical and microbial pesticides. CHAPTER 4 - HOW TO AMEND THE REGISTRATION OF A PRODUCT THAT IS ALREADY REGISTERED This chapter contains information on 1) how to amend the registration of your product after it has been registered by this Agency, 2) changes you may make to your registered product that do not require notification to the Agency that you have done so, and 3) changes you may make to your registered product, but which require prior notification to the Agency that you have done so. CHAPTER 5 - HOW TO APPLY FOR SUPPLEMENTAL REGISTRATION OF A REGISTERED PESTICIDE This chapter contains information on supplemental registration, that is your distribution and sale of a product that is registered by another company. CHAPTER 6 - WHAT ARE THE DATA COMPENSATION REQUIREMENTS This chapter contains information on data compensation and how you may comply with these requirements. CHAPTER 7 - HOW TO SUBMIT AN APPLICATION TO REQUEST A PETITION FOR A TOLERANCE, AN EXEMPTION FROM THE REQUIREMENT OF A TOLERANCE OR A TEMPORARY TOLERANCE This chapter contains information on when a petition to establish a tolerance for residue of a pesticide on food or feed commodities is required, and how to submit the petition. CHAPTER 8 - WHAT FEES ARE REQUIRED FOR REGISTRATION AND TOLERANCE PETITION ACTIVITIES This chapter contains information on the fees that are required to be paid to maintain your registration, and fees for petitions for the establishment of tolerances. CHAPTER 9 - HOW TO APPLY FOR AN EXPERIMENTAL USE PERMIT This chapter contains information on when you may need an experimental use permit which allows you to test an unregistered pesticide or a registered pesticide for an unregistered use, and how to submit the application. CHAPTER 10 - DEVICES - WHAT ARE THE REQUIREMENTS? This chapter contains information concerning devices. Although devices may not require registration under Chapter 3 of FIFRA, they may be subject to other regulatory requirements. CHAPTER 11 - HOW TO OBTAIN AN EPA ESTABLISHMENT NUMBER This chapter contains information on the registration of your pesticide producing establishment with the EPA, when you need an establishment number, and how to obtain one. CHAPTER 12 - HOW TO SUBMIT DATA AND CONFIDENTIAL BUSINESS INFORMATION This chapter contains information on the protection of information (and data) that you submit to the Agency in support of your registration, tolerance petition, and experimental use permits from disclosure or release to other persons, and the proper format for the submittal of that information and/or data. CHAPTER 13 - TRANSFER OF REGISTRATIONS AND/OR DATA This chapter contains information on the procedures and information required to transfer a registration and/or data from one company to another. CHAPTER 14 - STATE REGULATORY AUTHORITY UNDER FIFRA This chapter contains information on the authority of the States to issue experimental use permits and special local need registrations. CHAPTER 15 - OTHER TYPES OF REGISTRATIONS AND/OR APPROVALS THAT MAY BE NEEDED FROM OTHER FEDERAL OR STATE AGENCIES OTHER THAN PESTICIDE PROGRAMS This chapter contains information on the States' regulation of Federally registered pesticides, the regulation of the use of pesticides in meat and poultry plants by the U.S. Department of Agriculture, and the use of pesticides on food contact surfaces, for paper and paperboard (food uses), on medical devices, as human and animal drugs, and in cane-sugar and beet sugar-mills by both the EPA and the Food and Drug Administration. CHAPTER 16 - PUBLICATIONS AND HOW TO OBTAIN THEM This chapter contains information on the various types of publications concerning the registration, or regulation of pesticides and where they may be obtained. CHAPTER 17 - FORMS AND HOW TO OBTAIN THEM This chapter contains information on the forms required for various types of registration activities and where to obtain them. CHAPTER 18 - MAILING ADDRESSES AND WHO TO CONTACT FOR ASSISTANCE This chapter contains a list of specific individuals or offices to contact, if additional information is needed. GLOSSARY OF SELECTED TERMS, ABBREVIATIONS AND ACRONYMS INDEX