CFR

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 or part 161, as 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 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.

Code of Federal Regulations

[49 FR 30903, Aug. 1, 1984, as amended at 72 FR 61028, Oct. 26, 2007]

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