CHAPTER 6 - WHAT ARE THE DATA COMPENSATION REQUIREMENTS A. GENERAL INFORMATION By the late 1960's the amount of scientific data that was required to support the registration of a pesticide began to increase rapidly. Applicants and registrants who were required to generate these data, which were quite costly, asked Congress to provide protection for their investment, since by the time they obtained their registration or amended registration, most of or all of the pesticide's patent life had expired. Other registrants were then able to obtain a registration for the same type of product by relying on the data generated by the original data submitter, without having to share the burden of the cost of generating the data. In response to this concern, Congress amended the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) in 1972. Section 3(c)(1)(D) of the amended FIFRA (which was changed to 3(c)(1)(F)) placed data compensation obligations on those applicants for registration of a pesticide who would use the data submitted by another applicant or registrant in support of their own application for registration. In 1978, a second amendment to FIFRA granted "exclusive use" rights, for a 10 year period, to the original data submitter for certain data that were submitted to support the first registration of a product containing a new pesticide (active ingredient) or combination of active ingredients. An applicant must satisfy these data compensation requirements to obtain a registration, reregistration, or amend the registration of a registered product. In order for the Agency to evaluate your application for registration or to amend the registration of a registered product, data must be submitted to support the application or amendment. The applicant is responsible for supplying the data necessary for the Agency to make this evaluation. You may address the data requirements in several ways. One method is to develop and submit all of the data necessary to support your application, a second method would be to rely on data that has been submitted to the Agency by other applicants in support of their applications for registration, and a third method would be to develop some of the data to support your application and to rely on other's data to complete your data requirements. If you rely on data that were developed and submitted to the Agency in support of another persons application for registration, you must comply with the data compensation provisions of section 3(c)(1)(F) [formerly 3(c)(1)(D)] of FIFRA. Section 3(c)(1)(D) [now 3(c)(1)(F)] established two categories of data. 1. One category of data pertains to that data submitted in support of the registration of a pesticide containing active ingredients that were first registered after September 30, 1978, and to the data submitted with an application to add a new use to the original registration. These data are termed "exclusive use" data and the Agency may not consider these data to support your application for registration for a period of 10 years after the date of initial registration, unless you have written authorization from the original data submitter authorizing the Agency to use these data to support your application. After the 10 year "exclusive use" period has expired, you may still be required to offer to compensate the data submitter for use of the data, but written authorization from the data submitter is no longer needed. 2. The second category of data pertains to data submitted after December 31, 1969, in support of an application for registration, experimental use permit, or amendment adding a new use to an existing registration, to support or maintain an existing registration, or for reregistration. The Agency may, without the permission of the original data submitter, consider such data to support an application by another applicant within the 15 year period following the date the data were originally submitted to EPA only if the applicant has certified to the Agency that he/she has made an offer to compensate the original data submitter. 40 CFR Parts 152.80-99 and 152.116-119 provide detailed information on how you may comply with the data compensation provisions of FIFRA section 3(c)(1)(F). B. WHEN MUST YOU COMPLY WITH THE DATA COMPENSATION PROCEDURES? 1. The data compensation procedures apply to the following: a. Each application for registration of a new product, and b. Each application for an amendment of a registration, except as noted below. 2. The data compensation procedures do not apply to the following types of registration applications: a. Applications for experimental use permits, or b. Applications to make the following amendments to existing registrations unless it is determined that scientific data would be necessary: 1) An increase or decrease in the percentage of one or more of the active ingredients or deliberately added inert ingredients in a product, 2) A revision of the identity or amount of impurities in the product, 3) The addition or deletion of one or more deliberately added inert ingredients, 4) The deletion of one or more active ingredients, 5) A change in the source of supply of one or more of the active ingredients used in the product, if the new source of the active ingredient is a product which is registered under section 3 of FIFRA, 6) Deletion of approved uses from the label, 7) Redesign of the label format, which involve no substantive changes in the directions for use, claims, representations, or precautionary statements, 8) Change in the product name, or addition of an additional brand name, 9) Clarification of directions for use, 10) Corrections of typographical errors, 11) Changes in the registrant's name and address, 12) Adding or deleting supplemental registrants (distributors), 13) Changes in the package or container size, 14) Changes in warranty, warranty disclaimer, or liability limitation statements, or addition or deletion of such statements, 15) "Splitting" the label for the purpose of marketing the product in different geographic regions with appropriate labels, where each amended label will contain previously approved use instructions (and related label statements) appropriate to a particular geographic region, and 16) Any other type of amendment, if the Agency determines that scientific data would not be needed in order to approve the amendment. C. WHAT INFORMATION MUST YOU SUBMIT WITH YOUR APPLICATION FOR REGISTRATION OR AMENDED REGISTRATION ? 1. FORMULATOR'S EXEMPTION STATEMENT (EPA Form 8570-27) Under FIFRA section 3(c)(2)(D) you are excused (i.e., eligible for the formulator's exemption) from the requirement to submit or cite data pertaining to the safety of any ingredient, or mixture of ingredients, contained in your product if the source(s) of each of these ingredients is an EPA registered product, and you purchase each active ingredient from another producer. a. Application for registration - If your product contains one or more active ingredients eligible for the formulator's exemption, you need not comply with the requirements of 40 CFR 152.90 through 152.96, with respect to any data requirements pertaining to the safety of these ingredients provided you submit a completed Formulator's Exemption Statement (EPA Form 8570-27) with your application for registration. b. Application for amended registration - You are not required to submit a new Formulator's Exemption Statement if your current statement on file with the Agency is complete and accurate. However, if you change from a registered source of any active ingredient to an unregistered source, you are required to submit an application for amended registration, together with a revised Confidential Statement of Formula. If your new source of the ingredient is not registered, you are no longer eligible for the formulators's exemption for that ingredient. IMPORTANT NOTE: Since data costs associated with EPA's reregistration program has caused many basic producers to request the deletion of uses which are important to many users, special provisions are made available to third party data producers which may affect the availability of the formulators' exemption to certain registrants. Refer to PR Notice 91-8 for important details. 2. Certification With Respect to Citation of Data (EPA Form 8570-29) The Agency has developed this form to enable you to certify how you will comply with data compensation requirements under FIFRA section 3(c)(1)(F). In order to comply with the FIFRA section 3(c)(1)(F) data compensation requirements, you must: a. Submit an acknowledgement of reliance on data in accordance with 40 CFR 152.86(d) you must include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) your application relies on the following data: 1) All data submitted with or specifically cited in your application, and 2) Each item of data in the Agency's files which: (a) concerns the properties or effects of your product, of any product which is identical or substantially similar to your product, or of one or more of the active ingredients in your product, and (b) Is one of the types of data the Agency would require to be submitted if you sought initial registration under FIFRA section 3(c)(5) of a substantially similar or identical product, at the time the Agency approves your application for registration. Item 1 on the Certification with Respect to Citation of Data form (EPA Form 8570-29) satisfies this acknowledgement requirement. b. Exclusive use data certification - Effective beginning September 30, 1978, exclusive use data pertains to those data that were submitted to the Agency in support of the registration of a new active ingredient, a new combination of active ingredients, or an application to amend the original registration to add a new use, for a period of 10 years after the initial registration has been issued. In order for the Agency to consider these data in support of your application for registration or amendment, you must in accordance with 40 CFR 152.86(a) certify to the Agency that you have obtained from each data submitter listed on the Data Submitters List, and/or the bibliography of an applicable Registration Standard, as an exclusive use data submitter written authorization which contains at least the following information: 1) Identification that you are the applicant to whom the authorization is granted, 2) Written authorization has been granted to you by the data submitter to allow the Agency to use all applicable data to satisfy the data requirements for the application in question, and 3) The signature and title of the original data submitter or his authorized representative and the date of authorization. If the Agency identifies any exclusive use data submitter not on the Data Submitters List or in the bibliography of a published Registration Standard, you will also be required to obtain written authorization from that person. (The Data Submitters List is a listing of data submitters which are listed under the active ingredient chemical code numbers. Refer to Chapter 16 of this manual for information on how to obtain the Data Submitters List. A source of published Registration Standards and Registration Eligibility Documents (REDs) is also listed in Chapter 16.) Item 2 on the Certification with Respect to Citation of Data form (EPA Form 8570-29) satisfies this exclusive use certification requirement. IMPORTANT NOTE: You must submit with your application a copy of the letter of authorization from the exclusive use data submitter authorizing use of these data by the Agency, to support your application for registration. c) Data other than exclusive use data - You must, in accordance with 40 CFR 152.86(b), certify to the Agency that with respect to each other data submitter on the Data Submitters List, and/or the bibliography of an applicable Registration Standard [40 CFR 152.90(a)(1)] or RED, for the active ingredient in question: 1) You have obtained from that person written authorization containing the information identified above under "Exclusive use data" or, 2) You have furnished to that person: (a) A notification of your intent to apply for registration, including the name and a list of the active ingredients in the proposed product, (b) An offer to pay the person compensation, to the extent required by FIFRA section 3(c)(1)(F), for any data required to support your application, (c) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of the data, and (d) Your name, address, and telephone number. Item 3 on the Certification with Respect to Certification of Data form (EPA Form 8570-29) provides methods for satisfying these requirements. d. Methods for complying with the data compensation requirements of FIFRA section 3(c)(1)(F) - There are two methods of complying with the data compensation requirements, these are 1) the "cite-all" method and 2) the "selective" method of support. These two methods are described below. In addition, a table (Appendix 6-1 which follows section E of this Chapter) comparing these methods is also provided. 1) THE CITE-ALL METHOD OF SUPPORT - You may comply with the data compensation requirements under the cite-all method (40 CFR 152.86) for your application to register a new product or to amend a product you already have registered by: (a) citing all pertinent data in the Agency's files involving "exclusive use" data only with the written permission of the exclusive use data submitter, or (b) citing all pertinent data in the Agency's files, no exclusive use data involved, with permission of the original data submitter or by offering to pay compensation for use of the data in accordance with FIFRA section 3(c)(1)(F), and (c) submitting to the Agency a General offer to pay statement, in accordance with 40 CFR 152.90(c), in which you state your offer and agree to pay compensation to other data submitters to the extent required by FIFRA section 3(c)(1)(F). If you check the first box in item 3 of the Certification with Respect to Citation of Data form (EPA Form 8570-29), and sign the General Offer to Pay statement at the bottom of the form, you are certifying to the Agency that you have complied with these requirements. IMPORTANT NOTE: In accordance with 40 CFR 158.99, an original data submitter may petition the Agency to deny or cancel your registration if he has submitted a study that he claims satisfies a data requirement and for which you have either failed to receive authorization to use, or have not made a proper offer to pay compensation. 2) THE SELECTIVE METHOD OF SUPPORT - You may comply with the data compensation requirements under the selective method by listing the specific data requirements that apply to your product, its active ingredients, and use patterns, and demonstrating compliance with the data requirements by either submitting the actual studies, or citing individual studies, or by demonstrating that no study has been previously submitted to the Agency (a data gap). Refer to 40 CFR 152.90 for a detailed discussion of the selective method, and sections 152.91 through 152.96 for specific procedures for citing or submitting a study or for demonstrating a data gap. IMPORTANT NOTE: The Data Gap option may not be available to certain applicants, i.e., those seeking the registration of a product containing a new active ingredient or those seeking to add a new use pattern to a registered product. If you chose the Selective Method of complying with the data compensation requirements you must: (a) submit the Certification with Respect to Citation of Data form (EPA Form 8570-29) on which you have checked the second box in item 3, indicating you have chosen the Selective Method, and (1) sign the signature block immediately below, or (2) if you are using the cite all option under the Selective Method to address specific data requirements [see b)(2)(iii) and (iv) below], sign the last signature block on the form. b) submit a data matrix chart which addresses the items listed below. Refer to Appendix 6-2, which follows section E. of this Chapter, for a sample data matrix format and instructions on how to complete it. (1) List of data requirements applicable to your product [see 40 CFR 152.90(a)]. The list must be based on the data guidelines in 40 CFR Part 158 - Data Requirements for Registration, a Registration Standard or a Reregistration Eligibility Document (RED) for the active ingredient(s) in your product, if applicable. Refer to Chapter 16 of this manual for a source of the Registration Standards that have been issued. (2) How you intend to satisfy each of the data requirements identified on the data matrix chart. There are several ways to satisfy these data requirements. (i) Reference data originally submitted to the Agency by you, the applicant [See 40 CFR 152.93(a)]. (ii) Reference data previously submitted to the Agency by someone other than you and obtain their permission to cite the data. You must certify that you have obtained written authorization from the original data submitter. For an exclusive use procedures outlined in section C.2.a.1), must be followed. Refer also to 40 CFR 152.93(b)(1). (iii) Reference data previously submitted to the Agency by someone other then you (that is not an exclusive use study) and make a proper offer to pay to such person (40 CFR 152.93(b)(2). (iv) Reference all data in the Agency's files pertinent to the specific data requirement and make a proper offer to pay to all data submitters on the Data Submitter's List for those specific data (40 CFR 152.90). (v) Submit data not previously submitted or submit data from the public literature (40 CFR 152.94). (vi) Document waivers of data previously allowed by the Agency (40 CFR 152.91). Refer to Chapter 15 of this manual for information on how to obtain information on chemicals for which data waivers have been granted. (vii) Demonstrate that a data gap(s) exist. Submit a completed EPA Form 8570-28, Certification of Compliance with Data Gap Procedures (see 40 CFR 152.96). Note: The Data Gap option may not be available to certain applicants, i.e., those seeking the registration of a product containing a new active ingredient or those seeking to add a new use pattern to a registered product. IMPORTANT NOTE: The Data Tables and bibliography in an applicable Registration Standard and/or Reregistration Eligibility Document can be very helpful in developing a data matrix. D. DATA COMPENSATION CHARGES/PAYMENT DISPUTES 40 CFR 152, Subpart E - Procedures To Ensure Protection of Data Submitters' Rights [specifically 40 CFR 152.80; 152.86 (b)(2)(iii); 152.93 (b)(2)(iv); 152.95(b)(2)(iv); 152.99 (a)(i) and 152.99(a)(iii)] describes the procedures by which data submitters may challenge registration actions which allegedly failed to comply with FIFRA section 3(c)(1)(F). Applicants relying on another person's data to support their registration are required to certify to the Agency, with respect to each person on the Data Submitters List, for the chemical in question, an offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study. FIFRA sections 3(c)(1)(F)(ii) [formerly 3(c)(1)(D)(ii) and 3(c)(2)(B)(iii) states that the terms and amount of compensation may be fixed by agreement between the original data submitter and the applicant, or, failing such agreement, by binding arbitration under the procedure and rules of the Mediation and Conciliation Service. The arbitrator to be appointed from the roster of arbitrators maintained by such Service. The findings and determination of the arbitrator shall be final and conclusive, and no official or court of the United States shall have power or jurisdiction to review any such findings and determination, except for fraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator. All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. Refer to 29 CFR 1440 for details on the arbitration procedures. E. QUESTIONS AND ANSWERS The following questions are those most frequently asked by interested persons regarding data compensation procedures: 1. Question: What is a "me-too product"? Answer: The term "me-too product" refers to a pesticide product that is identical or substantially similar to another pesticide product that is currently registered by EPA. The term "identical product" means a product, when compared to a currently registered product: a) Contains the same active and intentionally added inert ingredients, and in the case of a technical grade product, the same impurities, each ingredient being the same percentage, and b) Includes identical or substantially similar uses. The term "substantially similar product" for a non- technical grade product, e.g., an end-use product, means a product when compared to a currently registered product: a) Contains the same active ingredients, b) The percentages of the active ingredients and the intentionally added inerts and their percentages may vary only to the extent that it is reasonable to conclude that the hazards are not different from those associated with the registered product, and c) Includes identical or substantially similar uses. The term "substantially similar product" for a non-end- use product, e.g., a manufacturing-use or a formulating-use only product (including technical grade products), means a product when compared to a currently registered product: a) Contains the same active ingredient, b) The percentage of the active ingredient and the impurities and their percentages may vary only to the extent that it can be reasonably established that the hazards are not different from those associated with the registered product, and c) Includes identical or substantially similar uses. 2. Question: When applying for a registration of a "me-too product" under the Cite-all Method of Support, must I submit additional information other than 1) a completed and signed Application for Registration form (EPA Form 8570-1), 2) a completed and signed Confidential Statement of Formula (EPA Form 8570- 4),3) proposed labeling, and 4) a completed and signed Certification With Respect to Citation of Data (EPA Form 8570- 29)? Answer: Yes, routinely more information is required. First, you must tell us the name and EPA registration number of the currently registered product that you believe your proposed product is identical with or substantially similar to. Second, since product chemistry data are specific to each formulation, you must submit the product chemistry required in 40 CFR section 158.20 unless you are certain that your proposed formulation is identical to the registered product you have cited to support your "me-too" claim. Please note however, that short of extensive chemical analysis, there are only a few ways to be certain that your proposed formulation is identical to the registered product you cite. These ways include situations where the cited product's label actually identifies each active and inert ingredient and associated percentages, or you produce or repackage the cited product. An Application for Amended Registration for an amendment involving data requirements would be a situation analogous to an application for registration of an identical product. If, during our review of your application, we find that the product you have cited as the "me-too" is not at least substantially similar to your proposed product, we will inform you that you are not eligible for the Cite-All Method of Support and will have to either identify another product as the "me- too" or proceed under the Selective Method of Support. If you chose to proceed under the Selective Method of Support you may have to actually generate data to support your application for registration. If you are eligible for the formulator's exemption, usually this will involve a requirement to submit product chemistry and acute toxicology data. Occasionally, efficacy data may also be required. In those cases where new chemicals or changed use patterns are involved, extensive data requirements may be imposed. 3. Question: After reading the regulations, it is my belief that if I simply repackage a registered technical grade, manufacturing-use or end-use product and use the same labeling, I need only claim the formulator's exemption under FIFRA section 3(c)(2)(D) and not submit any other information under the Cite- all or Selective Method of Support or include any product specific data, e.g., product chemistry, acute toxicity or efficacy data. Answer: You are correct provided you simply repackage another registered product and do not change the purchased formulation in any manner. In this case your application for registration would consist of an Application for Registration (EPA Form 8570-1), a Confidential Statement of Formula (EPA Form 8570-4), the Formulator's Exemption Statement (EPA Form 8570-27) and 5 copies of your draft labeling. 4. Question: When I submit an application for a "me-too" amendment to the registration of my product, and data is required to support the proposed amendment, under the data compensation requirements do I have to again offer to pay compensation for all of the data necessary to support the registration of the entire product, or only offer to pay compensation for the data necessary to support the amendment? Answer: Your entire product is subject to the data compensation provisions including your amendment. There are several reasons for this requirement. Data (either generic data or product specific data) may have been submitted to the Agency to fill data gaps since you first offered to pay compensation with your initial application for registration for your product, or when it was last amended. Also, some of the data initially used to support your registration may have been determined to be unacceptable and may have been replaced. As a result, if additional data are required to support the proposed amendment to your registration, your entire product including the proposed amendment is subject to the data compensation requirements of section 3(c)(1)(F) of FIFRA, within the limits prescribed by your eligibility under the formulator's exemption under section 3(c)(2)(D) of FIFRA. There are several possible situations, as discussed below, which are dependent on whether you choose the cite-all or selective method of support. It is assumed that you are eligible for the formulator's exemption for the active ingredient(s) in your product, and that your labeling claims, or use patterns, do not exceed those supported by the labeling of the product from which you are formulating. Cite-all Method of Support: If you wish to use the cite-all method of support (and you are eligible for the formulator's exemption), you must make written offers to pay to all of the data submitters listed on the Data Submitter's List who have claimed product specific types of data for each active ingredient in your product. Since product-specific chemistry data is generally required to be submitted by you to support your initial application for registration, and is unique to a particular formulated product, these data which were furnished by you would not normally be subject to the data compensation requirements. Acute toxicity data would be compensable since these data could support the registration of any number of similar or identical products, and are not necessarily product specific. If EPA has not issued a Registration Standard or RED for one or more of the active ingredients contained in your product, you must write all of the data submitters on the Data Submitters List for each of the active ingredients contained in your product. The offer to pay must identify your total product as well as your amendment. Selective Method of Support: If you wish to use the selective method of support (and you are eligible for the formulator's exemption) you must submit a data matrix chart with appropriate information as to how each data requirement is to be satisfied for your total product as well as for the amendment, taking into consideration the most up to date information, i.e., the data tables and bibliography in the most recent Registration Standard or Reregistration Eligibility Document(if any) or the data tables in 40 CFR Part 158. Since product-specific chemistry data is generally required to be submitted by you to support your initial application for registration, these data would not normally be required for an amendment to your registration. Acute toxicity data would need to be addressed, if additional acute toxicity data were required to support the amendment or a previously submitted study was invalidated. If a data matrix previously submitted in support of the product's initial registration or amendment is still valid, and no additional data are required, you may reference that data matrix in support of your current application for amended registration. If additional data are required to support your current amendment request, an updated data matrix should be submitted. 5. Question: I have obtained letters from companies on the Data Submitters List who say that they do not want any compensation for their data. May I use these letters as if they were giving me permission to use their data? Answer: You may not. The data submitter must explicitly grant permission and cannot be presumed to do so. However, only in the case of exclusive use is explicit permission required. Otherwise, if you go through the proper data compensation procedures, permission from the data submitter is not required. 6. Question: I have in my files a number of letters from data submitters that give me permission to use their data to support my application for registration. May I use these letters to support my application without getting new authorization? Answer: Yes, provided those letters are written to clearly state that they cover your present application either specifically or generically and they also give permission to use the relevant data to support your application for registration. If this is the case, you may certify to the Agency that you have received written permission to cite the data. The Agency will honor the terms and conditions of an original letter of authorization to cite data and will not accept a letter withdrawing that authorization unless both the original data submitter and the registrant(s) or applicant(s) relying on the data submitter's data agree that such authorization has been withdrawn. See PR Notice 91-6. 7. Question: If I have a product that contains multiple active ingredients, some of which are purchased from registered sources and others that are not, may I claim a formulator's exemption for those active ingredients that are purchased from registered sources? Answer: Yes, you may, unless use patterns on your label are not supported by your source. See PR Notice 91-8. Submit a properly completed Formulator's Exemption Statement (EPA Form 8570-27). 8. Question: May I use an unregistered source of an active ingredient to formulate my product. Answer: Yes, you may. It is not a violation of FIFRA to purchase and use an unregistered product in the formulation of your product. However, you should be aware that administrative complications and data requirements are reduced if your source of the active ingredient(s) is registered. Normally it is illegal under FIFRA to sell or distribute an unregistered pesticide, and this also pertains to unregistered sources of the active ingredient. However, in accordance with 40 CFR 152.30, you may use an unregistered source provided the source is: a. Reformulated into a registered product within the same registered establishment. b. Transferred from one EPA registered establishment to another EPA registered establishment, both of which are owned or leased by the same company. c. Transferred between two EPA registered establishments not operated by the same producer if: 1) the transfer is only for the purpose of further formulation, packaging or labeling into a product that is registered, and 2) each active ingredient in the pesticide, at the time of transfer, is present as a result of incorporation into the pesticide of either: i) a registered product; or ii) a pesticide that is produced by the registrant of the final product; and 3) the product as transferred is labeled in accordance with 40 CFR 156. d. Transferred by a producer who does not have actual or constructive knowledge that his product is intended to be used or is used for pesticidal purposes (40 CFR 152.15(c)). Therefore, should you decide to use an unregistered source of an active ingredient, you need to be aware that you are responsible for providing any information or data the Agency would need to accept that new source for registration. If the unregistered source is to replace the original registered source of an active ingredient in your currently registered product, it may not be added to your product until the Agency has approved the new unregistered source. Finally, you should also be aware that the use of an unregistered source of an active ingredient will cause you to be ineligible for the formulator's exemption provision under FIFRA section 3(c)(2)(D), at least for the active ingredient(s) from the unregistered source. 9. Question: May I use both the Selective and Cite-All Methods of Support for one product application, if I have more than one active ingredient in my product? Answer: Yes, you may. 10. Question: If I use the Cite-All Method of Support, do I also have to submit a list of data requirements and references? Answer: No, the cite-all method requires no accompanying list (or data matrix) such as that required for the selective method. 11. Question: I have sent offers to pay compensation to use data to support my application for registration or amendment to all data submitters listed on the most recent Data Submitter's List and if applicable the most recent Registration Standard or Reregistration Eligibility Document. I have not received any replies. How long do the data submitters have to respond to my offer to pay, and if they do not respond am I still liable to pay for data compensation? Answer: FIFRA and the regulations in 40 CFR do not require a registrant to respond to offers within a specific time frame to preserve data compensation rights. Accordingly, provided such data are compensable, a data submitter may request compensation at any time. 12. Question: If I write to a company on the Data Submitters' List via certified mail and my letter is returned with an indication that the data submitter's company cannot be located, how much more must I do to find the company? Answer: It is EPA's position that if you have obtained a certified or registered mail statement that there is no known address for that company, you have made a reasonable effort to notify that company. Of course, you may pursue the matter further if you wish. Indicate in your application what you have done to locate the data submitter. Should a data submitter wish to challenge a registration in the future because of not being notified, 40 CFR 152.99 provides for that situation. 13. Question: Who has to cite or submit residue chemistry data under the Selective Method of Support? Answer: Only applicants who do not qualify for the formulator's exemption under FIFRA section 3(c)(2)(D) must satisfy residue chemistry data requirements. Such applicants must obtain permission or make an offer to pay to use these data (if data exist), if they choose the Cite-All Method of Support. There may be exceptions, i.e., where the source of the active ingredient has not supported the use(s) you claim in your labeling. In such cases, applicants will be required to generate the necessary residue data. See PR Notice 91-8. There are other cases when residue chemistry data may be required, for example an applicant for registration of an end-use product in a substantially different form (e.g., an emulsifiable concentrate vs. a wettable powder) from that which is currently registered, may be required to submit additional residue chemistry data even if they are eligible for the formulator's exemption. 14. Question: If I am eligible for the formulator's exemption do I have to submit anything more than the Formulator's Exemption Statement (EPA Form 8570- 27) and the Confidential Statement of Formula (EPA Form 8570-4)? Answer: Yes, in addition to those forms, you must submit information required for either the Selective or the Cite- All Method of Support. Usually the data required for those eligible for the formulator's exemption are the product specific product chemistry and product specific acute toxicology data. 15. Question: Do I have to get permission from, or make an offer to pay, to the person who generated the data from the public literature that I have cited or submitted? Answer: No. 16. Question: If I am the first applicant/registrant to cite or submit a public literature data source, do I acquire data submitter's rights? Answer: No, applicants do not need permission to cite public literature. No one acquires "data submitters' rights" from public literature submissions. 17. Question: If I submit an application in which I declare one or more data gaps under the Selective Method of Support, without having waited for the 60 day period to elapse to receive a reply from all on the Data Submitters' List, will the Product Manager process my application? Answer: Yes. However, the Product Manager will not approve your application until you have certified that you have waited the required 60 days and no one has disputed your assertion that one or more data gaps exist as you have declared in your application. You may wish to await the 60 day period and certification before submitting your application to the Agency. 18. Question: If I submit an application to register a new product that contains an active ingredient for which the Agency has issued a Data Call-In (DCI), Registration Standard (RS), or Reregistration Eligibility Document (RED), am I subject to the data requirements in those documents as well as those in 40 CFR 158 or just those in 40 CFR 158 and am I subject to the Data Compensation regulations? Answer: You are subject to the all of the data requirements and submittal times set forth in 40 CFR 158 as well as the data requirements and submittal times set forth in any DCI issued by the Agency in connection with a RS, or RED, regardless of whether your new product is a technical grade product, manufacturing use product, or an end use product. If the timeframe for generating and submitting a given data set has past, then you must submit those data with your application or you may cite data submitted by someone else. If a timeframe has not yet past, then you must submit the required data by the date specified. If data gaps were declared in the RS or RED, you may rely on the RS or RED for the identification of those gaps. But, under the Selective Method of Support you must still provide a list of the requirements in accordance with 40 CFR 152.90(a), and may not simply cite the RS or RED. You may, however, indicate on your list of data requirements that the existence of a data gap is documented in the RS or RED. You are also subject to the Data Compensation requirements under 3(c)(1)(F) [formerly 3(c)(1)(D)] of FIFRA. Refer to PR Notice 85-3, 40 CFR 152.90 through 152.96 and 40 CFR 158 for full details on data requirements and to FIFRA Section 3(c)(1)(F) for data compensation information. 19. Question: If I am submitting a complete set of supporting data with the application, do I need to fill out the Certification form? Answer: No. So long as you are not submitting required data that has been previously submitted by another submitter. If you have previously submitted data you should cite those data rather than submit them again. 20. Question: Do I have to fill out all items under 2 and 3 on the Certification form? Answer: Mark only those items that are appropriate for your application. 21. Question: When does the 10 years "exclusive use" period expire for data generated 12 years after the first registrants? Answer: Data submitted 12 years after the original registration are not covered by exclusive use at all. Exclusive data rights exist only for the registrant who obtained the first registration that contains a new active ingredient or new mixture of active ingredients and only for that first registration and subsequent amendments to that original registration for a 10 year period. Data submitted 11 years after the date of the original registration are not covered by exclusivity. These data are covered by data compensation rights for another fifty years. E. GOOD LABORATORY PRACTICE STANDARDS - PHYSICAL AND CHEMICAL HAZARDS FOR PRODUCT SPECIFIC DATA. 40 CFR 160 sets forth good laboratory practices for conducting studies that support or are intended to support applications for registration, amended registration, or reregistration of a pesticide product, applications for an experimental use permit, petitions for establishment or modification of a tolerance or food additive regulation, exemptions from the requirement of a tolerance or food additive regulation. Although all studies have to be conducted in accordance with some of the good laboratory standards, only physical and chemical characterization studies to determine solubility, octanol water partition coefficient, stability (product chemistry data requirement 63-8, 63-10, 63-13 respectively), volatility, and persistence (such as biodegradation, photodegradation, and chemical degradation (environmental fate 163-2, 163-3, 161-1; 161-2; 161-3; and 161-4 respectively) studies are subject to the full good laboratory practice standards. All other studies are subject only to the good laboratory provisions set forth in 40 CFR 160.33, 41, 51, 61, 63, 83, 105(e), 107, 120(13) and (14), 130,185(a)(1) through (4), (9), (11), (13), 190, 195(a),(b),(e),(f),(g),(h),(i). F. WHO TO CONTACT FOR ADDITIONAL INFORMATION If you have any questions concerning the data compensation procedures and whether they apply to your application, please contact the appropriate Product Manager for your pesticide. Refer to Chapter 18 of this manual for a listing of the various Product Managers and the type of products for which they are responsible. G. REFERENCES CITED IN CHAPTER 6 - 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 152, Subpart E - Procedures to ensure protection of data Submitters' rights Part 158 - Data requirements for registration 2. Code of Federal Regulations, Title 29 Part 1440 - Arbitration of Pesticide Data Disputes 3. Federal Insecticide, Fungicide and Rodenticide Act, as amended October, 1988 Section 3 - Registration of pesticides 4. Food, Agriculture, Conservation, and Trade Act of 1990, November 28, 1990 Subtitle H - Pesticides; Sections 1491 through 1499 5. Food, Agriculture, Conservation, and Trade Act Amendments of 1991, December 13, 1991 Section 1006 - Amendments to FIFRA and Related Provisions 6. PR Notice 85-3 - Effective Date of Data Compensation Procedures under FIFRA, Issued by the Registration Division, Office of Pesticide Programs, EPA, May 14, 1985. 7. PR Notice 91-6 - EPA Policy Regarding Requests to Withdraw Authorization to Cite Data, Issued by the Registration Division, Office of Pesticide Programs, EPA, December 13, 1991. 8. PR Notice 91-8 - Revised Policy to Provide Applicants Other Than Basic Manufacturers An Opportunity To Submit Generic Data and Receive Data Compensation For It, Issued by the Registration Division, Office of Pesticide Programs, EPA, December 31, 1991. 9. Data Submitters' List 10. Listing of Registration Standards 11. Listing of Chemicals for Which Data Waivers Have Been Granted APPENDIX 6-1 COMPARISON OF THE CITE-ALL AND SELECTIVE METHODS OF SUPPORT +--------------------------------------------+--------+---------+ | | | | |If an applicant chooses this method ------> |Cite-all|Selective| |can he/she satisfy a data requirement |--------|---------| |by the means listed below? | | | | | | | |----------------------------+---------------|--------|---------| |1. Requesting and obtaining | | | | | a waiver | | No (1) | Yes | |----------------------------|---------------|--------|---------| |2. Submission of a new study| | No (1) | Yes | |----------------------------|---------------|--------|---------| |3. Citation of his/her own | | No (1) | Yes | | study | | | | |----------------------------|---------------|--------|---------| |4. Citation of another |a. With per- | | | | person's exclusive use | mission | No | Yes | | study |---------------|--------|---------| | |b. With offer | | | | | to pay | No | No | |----------------------------|---------------|--------|---------| |5. Citation of another |a. With per- | | | | person's study that is | mission | No | Yes | | not exclusive use |---------------|--------|---------| | |b. With offer | | | | | to pay | No | Yes | |----------------------------|---------------|--------|---------| |6. Citation of all pertinent|a. With per- | | | | studies in Agency files, | mission | Yes | Yes | | exclusive use studies |---------------|--------|---------| | involved |b. With offer | | | | | to pay | No | No | |----------------------------|---------------|--------|---------| |7. Citation of all pertinent|a. With per- | | | | studies in Agency files, | mission | Yes | Yes | | no exclusive use studies |---------------|--------|---------| | involved |b. With offer | | | | | to pay | Yes | Yes | |----------------------------|---------------|--------|---------| |8. Citation of public | | | | | literature study | | No | Yes | |----------------------------|---------------|--------|---------| |9. Documentation of a data | | | | | gap | | No | Yes | +----------------------------+---------------|--------+---------+ 1. It should be noted that applicants under the cite-all method will not be precluded from obtaining waivers, or submitting or citing their own studies, but that taking these actions would affect neither their obligation to cite all data, nor the procedures that require offers to pay or in certain cases, permission of each previous data submitter. Therefore, as the table indicates, none of the actions would suffice in and of itself, to demonstrate compliance under the cite-all method. Requesting a waiver would be of concern primarily to those who choose the selective method of demonstrating compliance. An applicant under the cite-all method might, nonetheless, wish to establish that a data requirement has been waived in order to reduce the amount of data needed for an incremental risk assessment, or to limit his obligation to pay compensation (as contrasted to his obligation to tender offers to pay compensation. Similarly, the submission of a new study or the citation of a previously submitted study will be of most interest to applicants under the selective method, which involves meeting individual data requirements rather than referencing all previously submitted data. While no applicant is precluded from submitting his own data, under the cite-all method submission of a new study or citation of an old study would be in addition to the citation of all other relevant data in EPA's files. Under the selective method, however, the applicant may submit his own study to satisfy a data requirement and thereby can avoid the need to offer to pay compensation for other studies in EPA's files that satisfy the same data requirement. APPENDIX 6-2 SAMPLE MATRIX FORMAT FOR DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT The following matrix is a sample of an acceptable matrix format that can be used to satisfy the data requirement in 40 CFR 152.90(a). Applicants for registration using the selective method must prepare a list of the data requirements (refer to 40 CFR 158 - Data Requirements for Registration) for their product and indicate how those requirements are being satisfied. You may use this sample matrix or you may develop a similar matrix to satisfy this requirement. The sample matrix has been developed for a typical product where the applicant qualifies for the formulator's exemption. If you are eligible for the formulator's exemption you may use the data requirements shown on this sample matrix as a guide for determining the requirements for your products. If you are not eligible for the formulator's exemption you may use the single page blank matrix as a guide to develop a list of the data requirements for your products. HOW TO COMPLETE THE SAMPLE MATRIX Block 1. Insert the name of your product. Block 2. Insert the EPA registration number or file symbol (if known) as appropriate, for your product. Block 3. Indicate whether you are eligible for the Formulator's Exemption by checking either yes or no. Block 4. Fill in the page number for that page as well as the total number of pages in your listing. Block 5. Fill in your company's name and address. Block 6. Insert the date of your application for registration or amended registration. Block 7. List the active ingredient(s) in your product. If you have more than one active ingredient in your product and one or more do not qualify for the formulator's exemption, you must fill out a separate list for each active ingredient that does not qualify for the formulator's exemption and one for all of the rest of the active ingredients that qualify for the formulator's exemption. If all of the active ingredients in your product qualify for the formulator's exemption, you need complete only one set of forms and list all of the active ingredients in this box. Block 8a. Indicate the Part 158 and guideline reference number for each data requirement applicable to your product. If a Registration Standard or a Reregistration Eligibility Document has been issued, the data requirements and their guideline reference numbers are listed in the Standard. Block 8b. Show the name of the test, e.g., Acute oral LD-50 - rat. Applicants who do not qualify for the formulator's exemption must cite or submit the acute toxicology battery of tests for both the active ingredient and the product as formulated (if they are different). Those who qualify for the formulator's exemption need cite or submit tests only for the product as formulated. Block 9a. Use this block if you, the applicant, are relying on your own data to satisfy the requirement. Indicate whether you are citing or submitting the data. See "CITING DATA" entry below. Block 9b. Indicate the date you originally submitted the data to EPA. Block 9c. Use this block if you are relying on data submitted by another company or individual. Insert the name of the company or individual who has rights to the data. Block 9d. If you cite data submitted by another company or individual you must have his permission to use the data to support your application or you must have made a proper offer to pay to that person. If you are certifying to having received permission, you should write in "P" in this block. If you are certifying to having made an offer to pay, write in "OTP" in this block. IMPORTANT NOTE: If the data you are citing are exclusive use data, you must have permission to cite the data. You may not comply by making an offer to pay. Block 9e. If you are relying on public literature to support your application check this block. If you check this block you must submit a copy of the data on which you rely. Block 9f. Check this block, if you believe that either (1) according to Part 158 and the guidelines, the data requirement is not applicable (NA) or, (2) the data requirement has been previously waived by EPA for similar products, or (3) you can satisfy the data requirements by some other means not provided on the matrix. You must attach an explanation sheet to this list which provides the rationale for using this block. Block 10. Insert the MRID (EPA's Master Record Identification) number, EPA accession number, or other EPA identification number. CITING DATA Applicants must indicate whether data submitted with the application have or have not previously been provided to the Agency by the applicant. Previously submitted data may not be resubmitted. Rather, such data should be cited and the following information given: a. The title of the study, author(s), data completed, test substance, identity of the laboratory performing the study (if any). b. EPA's Master Record Identification (MRID) Number or EPA's data catalogue accession number (if known). c. The identity of the original submitter. d. The date on which the cited data were originally submitted to the Agency. e. One of the following if the data were not originally submitted by you: 1) Evidence of transfer of ownership of rights to the data to you. 2) Certification of written permission from the original submitter to cite the data. 3) Certification that a proper offer to pay has been made to the original data submitter. (One certification suffices for all offers to pay.) (NPIRS Note: The original document presented these following 4 charts in horizontal (landscape) format. They must be printed in that format for clarity.) SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 1. PRODUCT NAME: |2. EPA REG.NO./FILE SYMBOL: |3. FORMULATOR'S EXEMPTION |4. PAGE | | SELECTED: | 1 OF 5. APPLICANT'S (COMPANY) NAME AND | | YES NO | ADDRESS: | | | |6. APPLICATION FOR |7. NAME OF ACTIVE INGREDIENT(S): | REGISTRATION DATED: | | | | | | MONTH DAY YEAR | 8. 40 CFR Part 158 - | DATA REQUIREMENTS |9. SOURCE OF DATA SATISFYING REQUIREMENT 8a. |8b. |9a. |9b. |9c. |9d. |9e. |9f. |10. Guide- |Name of Test |Submitted| Date |Submitted |Certificate |Public |N.A. or |MRID Number, line | | by |Submitted|by another |of Permis- |Litera- |Waiver or|EPA Accession Refer- | |Applicant| |person/firm|sion (P) or |ture |other |Number, or ence | | | |(give name)|Offer to | |(explain)|other Number | | | | |Pay (OTP) | | |identifying | | | | |enclosed: | | |number | | | | |indicate | | | | | | | |"P" or "OTP"| | | Section | | | | | | | | 158.190 |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 method| | | | | | | | for enforcement | | | | | | | | limits | | | | | | | 63-3 | Physical State | | | | | | | 63-5 | Melting Point | | | | | | | 63-6 | Boiling Point | | | | | | | SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 1. PRODUCT NAME: |2. EPA REG.NO./FILE SYMBOL: |3. FORMULATOR'S EXEMPTION |4. PAGE | | SELECTED: | 2 OF 5. APPLICANT'S (COMPANY) NAME AND | | YES NO | ADDRESS: | | | |6. APPLICATION FOR |7. NAME OF ACTIVE INGREDIENT(S): | REGISTRATION DATED: | | | | | | MONTH DAY YEAR | 8. 40 CFR Part 158 - | DATA REQUIREMENTS |9. SOURCE OF DATA SATISFYING REQUIREMENT 8a. |8b. |9a. |9b. |9c. |9d. |9e. |9f. |10. Guide- |Name of Test |Submitted| Date |Submitted |Certificate |Public |N.A. or |MRID Number, line | | by |Submitted|by another |of Permis- |Litera- |Waiver or|EPA Accession Refer- | |Applicant| |person/firm|sion (P) or |ture |other |Number, or ence | | | |(give name)|Offer to | |(explain)|other Number | | | | |Pay (OTP) | | |identifying | | | | |enclosed: | | |number | | | | |indicate | | | | | | | |"P" or "OTP"| | | Section | | | | | | | | 158.190 |PRODUCT CHEMISTRY | | | | | | | |(continued) | | | | | | | | | | | | | | | 63-7 | Density, bulk- | | | | | | | | density, or | | | | | | | | specific gravity | | | | | | | 63-8 | Solubility | | | | | | | 63-9 | Vapor Pressure | | | | | | | 63-10 | Dissociation | | | | | | | | constant | | | | | | | 63-11 | Octanol/water | | | | | | | | partition | | | | | | | | coefficient | | | | | | | 63-12 | pH | | | | | | | 63-13 | Stability | | | | | | | 63-14 | Oxidizing/ | | | | | | | | reducing reaction| | | | | | | 63-15 | Flammability | | | | | | | 63-16 | Explodability | | | | | | | SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 1. PRODUCT NAME: |2. EPA REG.NO./FILE SYMBOL: |3. FORMULATOR'S EXEMPTION |4. PAGE | | SELECTED: | 3 OF 5. APPLICANT'S (COMPANY) NAME AND | | YES NO | ADDRESS: | | | |6. APPLICATION FOR |7. NAME OF ACTIVE INGREDIENT(S): | REGISTRATION DATED: | | | | | | MONTH DAY YEAR | 8. 40 CFR Part 158 - | DATA REQUIREMENTS |9. SOURCE OF DATA SATISFYING REQUIREMENT 8a. |8b. |9a. |9b. |9c. |9d. |9e. |9f. |10. Guide- |Name of Test |Submitted| Date |Submitted |Certificate |Public |N.A. or |MRID Number, line | | by |Submitted|by another |of Permis- |Litera- |Waiver or|EPA Accession Refer- | |Applicant| |person/firm|sion (P) or |ture |other |Number, or ence | | | |(give name)|Offer to | |(explain)|other Number | | | | |Pay (OTP) | | |identifying | | | | |enclosed: | | |number | | | | |indicate | | | | | | | |"P" or "OTP"| | | Section | | | | | | | | 158.190 |PRODUCT CHEMISTRY | | | | | | | |(continued) | | | | | | | | | | | | | | | 63-18 | Viscosity | | | | | | | 63-19 | Miscibility | | | | | | | 63-20 | Corrosion | | | | | | | | characteristics | | | | | | | 63-21 | Dielectric break-| | | | | | | | down voltage | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Section | TOXICOLOGY | | | | | | | 158.340 | | | | | | | | 81-1 | Acute oral, | | | | | | | | toxicity, rat | | | | | | | 81-2 | Acute dermal | | | | | | | | Toxicity, rabbit | | | | | | | SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 1. PRODUCT NAME: |2. EPA REG.NO./FILE SYMBOL: |3. FORMULATOR'S EXEMPTION |4. PAGE | | SELECTED: | 4 OF 5. APPLICANT'S (COMPANY) NAME AND | | YES NO | ADDRESS: | | | |6. APPLICATION FOR |7. NAME OF ACTIVE INGREDIENT(S): | REGISTRATION DATED: | | | | | | MONTH DAY YEAR | 8. 40 CFR Part 158 - | DATA REQUIREMENTS |9. SOURCE OF DATA SATISFYING REQUIREMENT 8a. |8b. |9a. |9b. |9c. |9d. |9e. |9f. |10. Guide- |Name of Test |Submitted| Date |Submitted |Certificate |Public |N.A. or |MRID Number, line | | by |Submitted|by another |of Permis- |Litera- |Waiver or|EPA Accession Refer- | |Applicant| |person/firm|sion (P) or |ture |other |Number, or ence | | | |(give name)|Offer to | |(explain)|other Number | | | | |Pay (OTP) | | |identifying | | | | |enclosed: | | |number | | | | |indicate | | | | | | | |"P" or "OTP"| | | Section | | | | | | | | 158.340 |TOXICOLOGY | | | | | | | |(continued) | | | | | | | | | | | | | | | 81-3 |Acute inhalation | | | | | | | |toxicity, rat | | | | | | | 81-4 |Primary eye | | | | | | | |irritation, rabbit| | | | | | | 81-5 |Primary dermal | | | | | | | |irritation | | | | | | | 81-6 |Dermal sensiti- | | | | | | | |zation | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | SAMPLE MATRIX FORMAT - DATA REQUIREMENT LISTING FOR THE SELECTIVE METHOD OF SUPPORT 1. PRODUCT NAME: 32. EPA REG.NO./FILE SYMBOL: 33. FORMULATOR'S EXEMPTION 34. PAGE þ þ SELECTED: þ 5 OF 5. APPLICANT'S (COMPANY) NAME AND þ þ YES NO þ ADDRESS: þ þ 1 þ6. APPLICATION FOR þ7. NAME OF ACTIVE INGREDIENT(S): þ REGISTRATION DATED: þ þ þ þ þ 1 MONTH DAY YEAR 1 8. 40 CFR Part 158 - 3 DATA REQUIREMENTS þ9. SOURCE OF DATA SATISFYING REQUIREMENT 8a. 38b. þ9a. 39b. 39c. 39d. 39e. 39f. 310. Guide- þName of Test þSubmittedþ Date þSubmitted þCertificate þPublic þN.A. or þMRID Number, line þ þ by þSubmittedþby another þof Permis- þLitera- þWaiver orþEPA Accession Refer- þ þApplicantþ þperson/firmþsion (P) or þture þother þNumber, or ence þ þ þ þ(give name)þOffer to þ þ(explain)þother Number þ þ þ þ þPay (OTP) þ þ þidentifying þ þ þ þ þenclosed: þ þ þnumber þ þ þ þ þindicate þ þ þ þ þ þ þ þ"P" or "OTP"þ þ þ Section þ þ þ þ þ þ þ þ 158. þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ þ 1 1 1 1 1 1 1 1