[Code of Federal Regulations]
[Title 40, Volume 28]
[Revised as of July 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 40CFR725.33]

[Page 474-475]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
                  Subpart B--Administrative Procedures
 
Sec. 725.33  Incomplete submissions.

    (a) A submission under this part is not complete, and the review 
period does not begin, if:
    (1) The wrong person files the submission.
    (2) The submitter does not attach and sign the certification 
statement as required by Sec. 725.25(b).
    (3) Some or all of the information in the submission or any 
attachments are not in English, except for published scientific 
literature.
    (4) The submitter does not provide information that is required by 
sections 5(d)(1)(B) and (C) of the Act and Sec. 725.160 or 725.260, as 
appropriate.
    (5) The submitter does not provide information required by 
Sec. 725.25, 725.155, 725.255, 725.355, or 725.455, as appropriate, or 
indicate that it is not known to or reasonably ascertainable by the 
submitter.
    (6) The submitter has asserted confidentiality claims and has failed 
to:
    (i) Submit a second copy of the submission with all confidential 
information deleted for the public file, as required by 
Sec. 725.80(b)(2).
    (ii) Comply with the substantiation requirements as described in 
Sec. 725.94.
    (7) The submitter does not include any information required by 
section 5(b)(1) of the Act and pursuant to a rule promulgated under 
section 4 of the Act, as required by Sec. 725.25(f).
    (8) The submitter does not submit data which the submitter believes 
show that the microorganism will not present an unreasonable risk of 
injury to health or the environment, if EPA has listed the microorganism 
under section 5(b)(4) of the Act, as required in Sec. 725.25(g).
    (9) For MCANs, the submitter does not remit the fees required by 
Sec. 700.45(b)(1) or (b)(2)(vi) of this chapter.
    (b)(1) If EPA receives an incomplete submission under this part, the 
Director, or a designee, will notify the submitter within 30 days of 
receipt that the submission is incomplete and that the review period 
will not begin until EPA receives a complete submission.
    (2) If EPA obtains additional information during the review period 
for any submission that indicates the original submission was 
incomplete, the Director, or a designee, may declare the submission 
incomplete within 30 days after EPA obtains the additional information 
and so notify the submitter.
    (c) The notification that a submission is incomplete under paragraph 
(b) of this section will include:
    (1) A statement of the basis of EPA's determination that the 
submission is incomplete.
    (2) The requirements for correcting the incomplete submission.
    (3) Information on procedures under paragraph (d) of this section 
for filing objections to the determination or requesting modification of 
the requirements for completing the submission.
    (d) Within 10 days after receipt of notification by EPA that a 
submission is incomplete, the submitter may file written objections 
requesting that EPA accept the submission as complete or modify the 
requirements necessary to complete the submission.
    (e)(1) EPA will consider the objections filed by the submitter. The 
Director, or a designee, will determine whether the submission was 
complete or incomplete, or whether to modify the requirements for 
completing the submission. EPA will notify the submitter in writing of 
EPA's response within 10 days of receiving the objections.
    (2) If the Director, or a designee, determines, in response to the 
objection, that the submission was complete, the review period will be 
deemed suspended on the date EPA declared the submission incomplete, and 
will resume on the date that the submission is declared complete. The 
submitter need not correct the submission as EPA originally requested. 
If EPA can complete its review within the review period beginning on the 
date of the submission, the Director, or a designee, may inform the 
submitter that the

[[Page 475]]

running of the review period will resume on the date EPA originally 
declared it incomplete.
    (3) If the Director, or a designee, modifies the requirements for 
completing the submission or concurs with EPA's original determination, 
the review period will begin when EPA receives a complete submission.
    (f) If EPA discovers at any time that a person submitted materially 
false or misleading statements in information submitted under this part, 
EPA may find that the submission was incomplete from the date it was 
submitted, and take any other appropriate action.