[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: 40CFR152.96]



[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



[[Page 23]]



    (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 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.