[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: 40CFR152.97]



[Page 23-24]

 

                   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.  152.97  Rights and obligations of data submitters.



    (a) Right to be listed on Data Submitters List. (1) Each original 

data submitter shall have the right to be included on the Agency's Data 

Submitters List.

    (2) Each original data submitter who wishes to have his name added 

to the current Data Submitters List must submit to the Agency the 

following information:

    (i) Name and current address;

    (ii) Chemical name and common name (if any) of the active 

ingredient(s), with respect to which he is an original data submitter;

    (iii) For each such active ingredient, the type(s) of study he has 

previously submitted (corresponding to Guidelines reference numbers 

given in tables in 40 CFR part 158, if applicable), the date of 

submission, and the EPA registration number, file symbol, or other 

identifying reference for which it was submitted.

    (3) Each applicant not already included on the Data Submitters List 

for a particular active ingredient must inform the Agency at the time of 

submission of a relevant study whether he wishes to be included on the 

Data Submitters List for that pesticide.

    (b) Obligation to respond to data gap letters. An applicant who 

chooses to defer his obligation by demonstrating the existence of a data 

gap must write to each original data submitter for confirmation that the 

data submitter has not submitted a valid study that would satisfy the 

requirement. The original data submitter is not required to respond to 

such letters. However, if



[[Page 24]]



he fails to respond, the applicant is entitled to assume (and the Agency 

will act on the assumption) that the original data submitter has not 

submitted a study to satisfy the requirement. The data submitter may 

thereby limit his right to later challenge the applicant's claim if he 

fails respond in writing delivered to the applicant within 60 days of 

receipt of the applicant's data gap letter.