40 CFR 152.86 - The cite-all method.
An applicant may comply with this subpart by citing all data in Agency files that are pertinent to its consideration of the requested registration under FIFRA section 3(c)(5), in accordance with the procedures in this section, as applicable.
(a)Exclusive use studies. The applicant must certify to the Agency that he has obtained, from each person listed on the Data Submitters List as an exclusive use data submitter for the chemical in question, a written authorization that contains at least the following information:
(1) Identification of the applicant to whom the authorization is granted;
(2) Authorization to the applicant to use all pertinent studies in satisfaction of data requirements for the application in question; and
(2) He has furnished to that person:
(ii) An offer to pay the person compensation to the extent required by FIFRA section 3(c)(1)(F) for any data on which the application relies;
(iii) An offer to commence negotiations to determine the amount and terms of compensation, if any, to be paid for the use of any study; and
(iv) The applicant's name, address, and contact information, including telephone number and email address.
[Name of applicant] hereby offers and agrees to pay compensation to other persons, with regard to the approval of this application, to the extent required by FIFRA section 3(c)(1)(F) of the Federal Insecticide, Fungicide and Rodenticide Act.
(d)Acknowledgement of reliance on data. Each application filed under this section shall include an acknowledgement that for purposes of FIFRA section 3(c)(1)(F) the application relies on the following data:
(1) All data submitted with or specifically cited in the application; and
(2) Each other item of data in the Agency's files which:
(i) Concerns the properties or effects of the applicant's product, of any product which is identical or substantially similar to the applicant's product, or of one or more of the active ingredients in the applicant's product; and
(ii) Is one of the types of data that EPA would require to be submitted if the application sought the initial registration under FIFRA section 3(c)(5) of a product with composition and intended uses identical or substantially similar to the applicant's product, under the data requirements in effect on the date EPA approves the applicant's present application.