[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: 40CFR152.95]



[Page 22]

 

                   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.  152.95  Citation of all studies in the Agency's files pertinent to 

a specific data requirement.



    An applicant normally may demonstrate compliance for a data 

requirement by citation of all studies in the Agency's files pertinent 

of that data requirement. The applicant who selects this cite-all option 

must submit to the Agency:

    (a) A general offer to pay statement having the same wording as that 

specified in Sec.  152.86(c) except that the offer to pay may be limited 

to apply only to data pertinent to the specific data requirement(s) for 

which the cite-all method of support has been selected;

    (b) A certification that:

    (1) For each person who is included on the Data Submitters List as 

an original data submitter of exclusive use data for the active 

ingredient in question, the applicant has obtained a written 

authorization containing the information required by Sec.  152.86(a) for 

the use the any exclusive use study that would be pertinent to the 

applicant's product; and

    (2) For each person included on the current Data Submitters List as 

an original data submitter of data that are not exclusive use for the 

active ingredient in question, the applicant has furnished:

    (i) A notification of the applicant's intent to apply for 

registration, including the name of the proposed product, and a list of 

the product's active ingredients;

    (ii) Identification of the specific data requirement(s) for which 

the offer to pay for data is being made;

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

by FIFRA section 3(c)(1)(D);

    (iv) An offer to commence negotiations to determine the amount and 

terms of compensation, if any, to be paid for use of any study; and

    (v) The applicant's name, address and telephone number; and

    (c) An acknowledgment having the same wording as that specified in 

Sec.  152.86(d), except that it may be limited to apply only to data 

pertinent to the specific data requirement(s) for which the cite-all 

method of support has been selected.