[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: 40CFR152.83]



[Page 18]

 

                   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.  152.83  Definitions.



    As used in this subpart, the following terms shall have the meanings 

set forth in this section:

    (a) Data gap means the absence of any valid study or studies in the 

Agency's files which would satisfy a specific data requirement for a 

particular pesticide product.

    (b) Data Submitters List means the current Agency list, entitled 

``Pesticide Data Submitters by Chemical,'' of persons who have submitted 

data to the Agency.

    (c) Exclusive use study means a study that meets each of the 

following requirements:

    (1) The study pertains to a new active ingredient (new chemical) or 

new combination of active ingredients (new combination) first registered 

after September 30, 1978;

    (2) The study was submitted in support of, or as a condition of 

approval of, the application resulting in the first registration of a 

product containing such new chemical or new combination (first 

registration), or an application to amend such registration to add a new 

use; and

    (3) The study was not submitted to satisfy a data requirement 

imposed under FIFRA section 3(c)(2)(B);

    Provided that, a study is an exclusive use study only during the 10-

year period following the date of the first registration.

    (d) Original data submitter means the person who possesses all 

rights to exclusive use or compensation under FIFRA section 3(c)(1)(D) 

in a study originally submitted in support of an application for 

registration, amended registration, reregistration, or experimental use 

permit, or to maintain an existing registration in effect. The term 

includes the person who originally submitted the study, any person to 

whom the rights under FIFRA section 3(c)(1)(D) have been transferred, or 

the authorized representative of a group of joint data developers.

    (e) Valid study means a study that has been conducted in accordance 

with the Good Laboratory Practice standards of 40 CFR part 160 or 

generally accepted scientific methodology and that EPA has not 

determined to be invalid.