[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR152.86]



[Page 19-20]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 152_PESTICIDE REGISTRATION AND CLASSIFICATION PROCEDURES--Table of 

Contents

 

  Subpart E_Procedures To Ensure Protection of Data Submitters' Rights

 

Sec.  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

    (3) The signature and title of the original data submitter or his 

authorized representative and date of the authorization.



If the Agency identifies any exclusive use data submitter not on the 

Data Submitters List, the applicant will be required prior to 

registration to obtain the necessary written authorization from such 

person.

    (b) Other studies. The applicant must certify to the Agency that, 

with respect to each other person on the Data Submitters List for the 

chemical in question:

    (1) He has obtained from that person a written authorization that 

contains the information required by paragraphs (a) (1) through (3) of 

this section; or

    (2) He has furnished to that person:

    (i) A notification of his intent to apply for registration, 

including the name of the proposed product, and a list of the product's 

active ingredients;

    (ii) An offer to pay the person compensation to the extent required 

by FIFRA section 3(c)(1)(D) 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) His name, address and telephone number.

    (c) General offer to pay statement. The applicant must submit to the 

Agency the following general offer to pay statement:



    [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)(D) 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)(D) the application relies on the following data:



[[Page 20]]



    (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.