[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: 40CFR152.96]

[Page 22-23]
 
                   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. 152.96  Documentation of a data gap.

    Except as provided in paragraph (a) of this section, an applicant 
may defer his obligation to satisfy an applicable data requirement until 
the Agency requests the data if he can demonstrate, by the procedure in 
this section, that no other person has previously submitted to the 
Agency a study that would satisfy the data requirement in question.
    (a) When data gap procedures may not be used. (1) An applicant for 
registration of a product containing a new chemical may not defer his 
obligation by the procedure in this section, unless he can demonstrate 
to the Agency's satisfaction that the data requirement was imposed so 
recently that insufficient time has elapsed for the study to have been 
completed and that, in the public interest, the product should be 
registered during the limited period of time required to complete the 
study. Refer to FIFRA section 3(c)(7)(C).
    (2) An applicant for registration of a product under FIFRA section 
3(c)(7) (A) or (B) may not defer his obligation by the procedure in this 
section if the Agency requires the data to determine:
    (i) Whether the product is identical or substantially similar to 
another currently registered product or differs only in ways that would 
not substantially increase the risk of unreasonable adverse effects on 
the environment;
    (ii) If efficacy data are required, whether the product is 
efficacious; or
    (iii) Whether the new use would substantially increase the risk of 
unreasonable adverse effects on the environment, usually required when 
the application involves a new use of a product which is identical or 
substantially similar to a currently registered product.
    (b) Data gap listed in a Registration Standard. The applicant may 
rely on a data gap that is documented by a Registration Standard without 
submitting the certification required by paragraph (c) of this section. 
If the data gap listed in the Registration Standard has been filled 
since the issuance of the Standard, the Agency will notify the applicant 
and require him to choose another method of demonstrating compliance.
    (c) Certification of a data gap. Except as provided by paragraph (b) 
of this

[[Page 23]]

section, an applicant who wishes to claim that a data gap exists must 
certify to the Agency that:
    (1) The applicant has furnished, by certified mail, to each original 
data submitter on the current Data Submitters List for the active 
ingredient in question, a notice containing the following information:
    (i) The name and address of the applicant;
    (ii) The name of the product, and a statement that the applicant 
intends to apply for registration of that product;
    (iii) The name(s) of the active ingredient(s) in the procuct;
    (iv) A list of the data requirements for which the applicant intends 
to claim under this section that a data gap exists; and
    (v) A request that the data submitter identify, within 60 days of 
receipt of the notice, any valid study which he has submitted to the 
Agency that would fulfill any of the data requirement(s) listed.
    (2) The applicant has, within that 60-day period, received no 
response, or has received a negative response, from each person 
notified; and
    (3) The applicant has no basis to believe that any data have been 
submitted to the Agency that would fulfill the data requirement, and is 
entitled to claim that a data gap exists.
    (d) Requirement to obtain permission or make offer to pay. In 
responding to a data gap letter, the original data submitter is not 
deemed to have given his authorization for the applicant to cite any 
study which the data submitter identifies in his response. The applicant 
must seek and obtain specific written authorization from, or make an 
offer to pay to, the original data submitter to cite the identified 
study in order to demonstrate compliance for the data requirement. 
Nothing, however, precludes the applicant from requesting written 
authorization or making an offer to pay at the same time that he 
requests confirmation of a data gap.