[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: 40CFR720.65]

[Page 127-128]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                    Subpart D--Disposition of Notices
 
Sec. 720.65  Acknowledgment of receipt of a notice; errors in the notice; 
incomplete submissions; false and misleading statements.

    (a) Notification to submitter. EPA will acknowledge receipt of each 
notice by sending the submitter a letter that identifies the 
premanufacture notice number assigned to the new chemical substance and 
the date on which the review period begins. The review period will begin 
on the date the notice is received by the Office of Pollution Prevention 
and Toxics Document Control Officer. The acknowledgment does not 
constitute a finding by EPA that the notice, as submitted, is in 
compliance with this part.
    (b) Errors in the notice. (1) Within 30 days of receipt of the 
notice, EPA may request that the submitter remedy errors in the notice. 
The following are examples of such errors:
    (i) Failure to date the notice form.
    (ii) Typographical errors that cause data to be misleading or 
answers to any questions to be unclear.
    (iii) Contradictory information.
    (iv) Ambiguous statements or information.
    (2) In the request to correct the notice, EPA will explain the 
action which the submitter must take to correct the notice.
    (3) If the submitter fails to correct the notice within 15 days of 
receipt of the request, EPA may extend the notice period under section 
(5)(c) of the Act, in accordance with Sec. 720.75(c).
    (c) Incomplete submissions. (1) A submission is not complete, and 
the notification period does not begin, if:
    (i) The wrong person submits the notice form.
    (ii) The submitter does not sign the notice form.
    (iii) Some or all of the information in the notice or the 
attachments are not in English, except for published scientific 
literature.

[[Page 128]]

    (iv) The submitter does not use the notice form.
    (v) The submitter does not provide information that is required by 
section 5(d)(1) (B) and (C) of the Act and Sec. 720.50.
    (vi) The submitter does not provide information required on the 
notice form and by Sec. 720.45 or indicate that it is not known to or 
reasonably ascertainable by the submitter.
    (vii) The submitter does not submit a second copy of the submission 
with all confidential information deleted for the public file, as 
required by Sec. 720.80(b)(2).
    (viii) 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. 720.40(g).
    (ix) The submitter does not submit data which the submitter believes 
show that the chemical substance will not present an unreasonable risk 
of injury to health or the environment, if EPA has listed the chemical 
substance under section 5(b)(4) of the Act, as required in 
Sec. 720.40(h).
    (2)(i) If EPA receives an incomplete submission, the Director, or 
his or her delegate, will notify the submitter within 30 days of receipt 
that the submission is incomplete and that the notice review period will 
not begin until EPA receives a complete notice.
    (ii) If EPA obtains additional information during the notice review 
period that indicates the original submission was incomplete, the 
Director, or his or her delegate, may declare the submission incomplete 
within 30 days after EPA obtains the additional information and so 
notify the submitter.
    (3) The notification that a submission is incomplete under paragraph 
(c)(2) (i) or (ii) of this section will include:
    (i) A statement of the basis of EPA's determination that the 
submission is incomplete.
    (ii) The requirements for correcting the incomplete submission.
    (iii) Information on procedures under paragraph (c)(4) of this 
section for filing objections to the determination or requesting 
modification of the requirements for completing the submission.
    (4) Within ten 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 a complete notice or modify 
the requirements necessary to complete the submission.
    (5)(i) EPA will consider the objections filed by the submitter. The 
Director, or his or her delegate, 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 ten days of receiving the objections.
    (ii) If the Director, or his or her delegate, determines, in 
response to the objection, that the submission was complete, the notice 
review period will be deemed suspended on the date EPA declared the 
notice incomplete, and will resume on the date that the notice is 
declared complete. The submitter need not correct the notice as EPA 
originally requested. If EPA can complete its review within 90 days from 
the date of the original submission, the Director, or his or her 
delegate, may inform the submitter that the running of the review period 
will resume on the date EPA originally declared it incomplete.
    (iii) If the Director, or his or her delegate, modifies the 
requirements for completing the submission or concurs with EPA's 
original determination, the notice review period will begin when EPA 
receives a complete notice.
    (d) Materially false or misleading statements. If EPA discovers at 
any time that person submitted materially false or misleading statements 
in the notice, EPA may find that the notice was incomplete from the date 
it was submitted, and take any other appropriate action.