CHAPTER 12 - HOW TO SUBMIT DATA AND CONFIDENTIAL BUSINESS INFORMATION A. GENERAL INFORMATION Some of the information (and data) you must submit to EPA is protected by FIFRA from disclosure or release to certain persons under certain circumstances. These protections are found in FIFRA Section 10. A brief synopsis is given below. You may also make confidentiality claims covering information other than that described in FIFRA Section 10(d)(1)(A), (B), or (C). If such claims are made, you will have to substantiate each claim, and the EPA General Counsel will rule on each claim before any disclosure or release of the information is made. The substantiation process is provided to afford protection to certain information that is not explicitly described in FIFRA or EPA Regulations. Consider making claims of confidentiality only after carefully reading the citations listed in section B. of this chapter. Normally, we see very few claims of this type that qualify for confidential treatment. Data submitted in support of your application for registration, amendments to a registration, petitions for tolerance, experimental use permit, etc., must be submitted in a standard format in accordance with 40 CFR 158.32-33 and PR Notice 86-5. Refer to section C. of this chapter for a general discussion of these requirements. B. SYNOPSIS OF FIFRA SECTION 10 - CONFIDENTIAL BUSINESS INFORMATION In brief, Section 10 provides that health and safety data on registered or previously registered pesticides shall be made available to the public, except that it does not authorize the release of the following information cannot be released: 1. Information that discloses manufacturing or quality control processes. 2. Information that discloses testing for and measuring the quantity of deliberately added inert ingredients, and 3. Information that discloses the identity or percentage quantity of deliberately added inert ingredients. When data are submitted, information of the types 1, 2, and 3, above must be physically separated from the rest of the data (study) and placed in a confidential attachment to the study. (See PR Notice 86-5 for specific instructions about study formatting.) FIFRA Section 10(b) protects certain confidential business information, such as trade secrets and commercial or financial information. FIFRA Section 10(e) permits EPA to give confidential business information (CBI) you submit to its contractors who are helping to do the work of the Agency. Such contractors are bound to protect this information to the same extent as EPA staff. We provide notification to submitters of CBI that their data will be provided to a contractor. This is usually done by publishing a Notice in the Federal Register and always precedes giving the CBI to the contractor. FIFRA Section 10(g) prohibits the disclosure of information submitted by an applicant or registrant to any representative of a multinational pesticide producer or to anybody who intends to deliver such information to a multinational pesticide producer. FIFRA provides that in certain circumstances the EPA Administrator may disclose information that is otherwise protected. Such action is rare, and is described in FIFRA Section 10(b), 10(d)(3), and 10(g). Information about registered pesticide products that can be released is normally not released until 30 days after the product is registered. See FIFRA Section 3(c)(2)(A). This has been a very brief review of certain points about CBI that may be of special interest to you. Please also see: FIFRA Section 10, 40 CFR 2.307, and the citations listed in 40 CFR 2.307(c). IMPORTANT NOTE: Documents containing CBI, i.e., a Confidential Statement of Formula (CSF), should not be transmitted over FAX machines unless the sender wants to clearly waive his or her CBI rights and states this on the documents being "FAXed." C. HOW TO SUBMIT DATA The following discussion highlights some of the more important points that you should follow when submitting data. You should also refer to 40 CFR 158.32-33 and PR Notice 86-5 for a more detailed discussion of how to format your data submission When you submit data, the data will be reviewed to determine whether it meets the data formatting requirements set forth in PR Notice 86-5. If major problems are found during this screening process, the studies will be returned to you for correction. Studies that meet the formatting requirements will be assigned a The following individuals in the Information Services Branch of OPP's Program Management and Support Division may be contacted for assistance in answering questions or to provide guidance concerning the data formatting procedures as required by PR Notice 86-5: Theresa Downs (703) 305-5363, Maureen Sherrill (703) 305-5361, Kris Pappajohn (703) 305-5316. Master Record Identifier (MRID) number and entered into the Agency's Pesticide Document Management System. These studies are then able to be retrieved by the MRID number at any time. You may refer to these MRID numbers in lieu of sending in additional copies of these data to support additional applications for registration. The following diagrams are meant to provide guidance on how to format your data submission. Again you should refer to PR Notice 86-5 for more detailed information. FORMAT OF THE SUBMITTAL PACKAGE APPLICATION TRANSMITTAL DATA TRANSMITTAL +------+ | (submit one copy only) -----> | | | | | | | | | | | +------+ | | +------+ | | | +------+ | |<--+ +-----> |+ +------+ | |-+ | +| || | |+ | | | | || || | || +-| | | | || ||+ +| || | | | | (submit | |+------+|| || || | +------+ |-+ | | | STP || || ||+ | | STP | | 3 copies)| | +------+| |+------+|| | +------+ | +---| | SOCC | |+ | | STP || | SOCC | | | | +------+ || | +------+| +------+ |-+ | | | |GLP/FS|| | SOCC | |+ | |GLP/FS| | | | | +------+| +------+ || | +------+ | | | | BOS | | | |GLP/FS|| | BOS | | | | +------+ | | +------+| +------+ | | | | ATS | | BOS | | | ATS | | +-> +------+ +------+ | +------+ | | ATS | | (copy #1) +------+ (copy #3) | v (copy #2) Studies submitted as unique physical entities, according to the format below. NOTE: As indicated in the above illustration, three identical copies of the data transmittal must be submitted. LEGEND: STP = Study title page. SOCC = Statement of confidentially claims. GLP/FS = Good Laboratory Practice (GLP) and flagging*. BOS = Body of study, in English. ATS = Appendices to the study. * Refer to 40 CFR 158.34. FORMAT OF THE SUBMITTED STUDIES +------+ | <------- Study title page. | | | |--+ | | <------ Statement of confidentially claims. | STP | |--+ +------+ | <------ Good Laboratory Practice (GLP) and flagging* | | | statements (as appropriate). | SOCC | |--+ +------+ | | |GLP/FS| <------- Body of study, in English. +------+ |---+ | | | | BOS | | +------+ | | <----- Appendices to the study | ATS | +------+ +------+ | |---+ Title Page of the -----> | <------- Confidential Attachment. Confidential | | |---+ Attachment. | | | | +------+ | <--- Supplemental Statement | | | of Confidentiality +------+ | Claims. | | +------+ +------+ * Refer to 40 CFR 158.34 LEGEND | | | |---+ +--------> | | | | | <---- Miscellaneous documents submitted | | | | at your option. | +------+ | | | | | +------+ | | | Documents which must be submitted as appropriate | to meet established requirements. v 1. APPLICATION TRANSMITTAL The application transmittal may include any or all of the following: a. Application forms b. Formulator's exemption statements c. Confidential Statement of Formula d. Certification with Respect to Citation of Data e. Data requirement matrices f. Data waiver request and supporting rationales g. Labeling IMPORTANT NOTE: PR Notice 86-5 does not change the registration requirements for applications for registration or amendments as set forth in 40 CFR 152 and elsewhere. PR Notice 86-5 only applies when you submit data to support the application, and then only to the data. All of the items listed in this sub- section address non-data requirements for registration, and are filed in the Agency's registration jacket (file) for your product. Thus they need not be submitted in three copies like the data. 2. DATA TRANSMITTAL DOCUMENT You should provide a copy of the Data Transmittal for each set of studies. Bind it separately, and be certain that it itemizes all studies that are physically included in the submittal. You will be sent a copy of your data transmittal document with the MRID numbers assigned to each piece of data or study. Refer to PR Notice 86-5 for a sample transmittal document. 3. BIND STUDIES SEPARATELY If a study addressed several data requirements, do not include it in your submittal more than once. Identify its full subject scope on its title page, and then cite the same study in your application in all appropriate contexts. Each study must be separately bound. Confidential attachments and supplemental statements of data confidentially must be included within the binding of the body of the study. All bindings must be secure, but easily removable to permit microfilming. 4. WHAT TO INCLUDE IN A STUDY All study-specific supplements, addenda, supporting analyses, protocols, or correspondence submitted at the same time as the report of the study itself should be included within the binding and pagination of the primary study. 5. IDENTIFYING SUPPLEMENTS TO PREVIOUSLY SUBMITTED STUDIES Whenever you submit information to supplement a previously submitted study, whether at your own initiative or in response to a request by EPA, it must be prepared in the format required by PR Notice 86-5. Submit three complete sets under an appropriate transmittal document, including supplemental information for only one study in each binding, and identifying the previously submitted study in supplements as clearly as possible, i.e., by EPA Accession Number or (preferably if you know it) the Master Record Identifier (MRID) number on its title page. 6. STATEMENT OF DATA CONFIDENTIALITY CLAIMS Each submitted study must have this Statement. The exact text of one of the two alternative forms of the statement (Refer to PR Notice 86-5) must appear on page 2 of the study. You may add to the required text a reference to the proprietary nature of the document, and you may assert that it may not be copied, quoted, etc. by any recipients other than EPA. You may not, however, assert a right of prior approval for use, copying, or distribution of the data by EPA, as required and constrained by Sections 3 and 10 of FIFRA. If there are markings (such as "Company Confidential") in your study documents, you must add to the required text an explicit statement that over-rides the implicit supplemental claims of confidentiality that result from these markings. This over-ride statement may specify that it applies only to use of the data by EPA in connection with the provisions of FIFRA. IMPORTANT NOTE: Documents for which a statement of data confidentiality claim has been made should not be transmitted over FAX machines unless the sender wants to clearly waive his or her CBI rights and states this on the documents being "FAXed." D. WHO TO CONTACT FOR ADDITIONAL INFORMATION: If you have any questions concerning confidential business information as it may concern your application or how to format and submit supporting data, please contact the Information Resources Development Section, Information Services Branch, Program Management and Support Division. Refer to Chapter 18 of this manual. E. REFERENCES CITED IN CHAPTER 12 - Refer to Chapter 16 for information on the source of these documents. 1. Code of Federal Regulations, Title 40 Part 2 - Public information 2. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 3 - Registration of pesticides Section 10 - Protection of trade secrets and other information 3. PR Notice 86-5 - Standard format for data submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and certain provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), Issued July 29, 1986. 4. PR Notice 89-3 - Format standards for Reregistration Phase 3 summaries and reformatted versions of studies previously submitted under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) and certain provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). Issued December 20, 1989.