[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: 40CFR152.93]



[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).



[[Page 22]]