[Code of Federal Regulations]
[Title 40, Volume 21]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR152.93]

[Page 21]
 
                   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. 152.93  Citation of a previously submitted valid study.

    An applicant may demonstrate compliance for a data requirement by 
citing a valid study previously submitted to the Agency. The study is 
not to be submitted to the Agency with the application.
    (a) Study originally submitted by the applicant. If the applicant 
certifies that he is the original data submitter, no documentation other 
than the citation is necessary.
    (b) Study previously submitted by another person. If the applicant 
is not the original data submitter, the applicant may cite the study 
only in accordance with paragraphs (b) (1) through (3) of this section.
    (1) Citation with authorization of original data submitter. The 
applicant may cite any valid study for which he has obtained the written 
authorization of the original data submitter. The applicant must obtain 
written authorization to cite any study that is an exclusive use study. 
The applicant must certify that he has obtained from the original data 
submitter a written authorization that contains at least the following 
information:
    (i) Identification of the applicant to whom the authorization is 
granted;
    (ii) Identification by title, EPA Accession Number or Master Record 
Identification Number, and date of submission, of the study or studies 
for which the authorization is granted;
    (iii) Authorization to the applicant to use the specified study in 
satisfaction of the data requirement for the application in question; 
and
    (iv) The signature and title of the original data submitter or his 
authorized representative, and date of the authorization.
    (2) Citation with offer to pay compensation to the original data 
submitter. The applicant may cite any valid study that is not subject to 
the exclusive use provisions of FIFRA section 3(c)(1)(D)(i) without 
written authorization from the original data submitter if the applicant 
certifies to the Agency that he has furnished to the original data 
submitter:
    (i) A notification of the applicant's intent to apply for 
registration, including the proposed product name and a list of the 
product's active ingredients;
    (ii) Identification of the specific data requirement involved and of 
the study for which the offer to pay is made (by title, EPA Accession 
Number or Master Record Identification Number, and date of submission, 
if possible);
    (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 the use of the study; and
    (v) The applicant's name, address and telephone number.
    (3) Citation without authorization or offer to pay. The applicant 
may cite any valid study without written authorization from, or offer to 
pay to, the original data submitter, if:
    (i) The study was originally submitted to the Agency on or before 
December 31, 1969; or
    (ii) The study was originally submitted to the Agency on or before 
the date that is 15 years before the date of the application for which 
it is cited, and the study is not an exclusive use study, as defined in 
Sec. 152.83(c).