[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: 40CFR720.40]

[Page 121-123]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                         Subpart C--Notice Form
 
Sec. 720.40  General.


    (a) Use of the notice form; electronic submissions. (1) Each person 
who is required by subpart B of this part to submit a notice must 
complete, sign, and submit a notice containing the information in the 
form and manner specified in this paragraph. The information submitted 
and all attachments (unless the attachment appears in the open

[[Page 122]]

scientific literature) must be in English. All information submitted 
must be true and correct.
    (2) Information may be submitted on paper, or electronically, as 
follows:
    (i) Information submitted on paper must be submitted in the form and 
manner set forth in EPA Form No. 7710-25, which is available from the 
Environmental Assistance Division (7408), Office of Pollution Prevention 
and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., 
NW., Washington, DC 20460. Information which is not submitted on the EPA 
Form No. 7710-25 or a photocopy thereof (e.g., on a form created by 
commercial form-making software) must be in a format pre-approved by the 
Agency.
    (ii) Information may be submitted electronically (on magnetic or 
other media) pursuant to an EPA published format for electronic 
submissions. Such submissions must comply with this format and all other 
media specifications published by EPA. Persons submitting electronically 
must still complete and submit on paper the Certification and Submitter 
Identification sections of Form 7710-25.
    (b) When to submit a notice. Each person who is required to submit a 
notice must submit the notice at least 90 calendar days before 
manufacture or import of the new chemical substance for commercial 
purposes begins.
    (c) Where to submit a notice. Each person who submits a notice must 
submit it to the address listed on the notice form.
    (d) General notice requirements. (1) Each person who submits a 
notice must provide the information described in Sec. 720.45 and 
specified on the notice form, to the extent such information is known to 
or reasonably ascertainable by the person. In accordance with 
Sec. 720.50, the notice must also include any test data in the person's 
possession or control, and descriptions of other data which are known to 
or reasonably ascertainable by the person and which concern the health 
and environmental effects of the new chemical substance.
    (2) A person who submits a notice to EPA under this part must 
provide EPA with an original and two complete copies of the notice, 
including all test data and any other information attached to the notice 
form. If information is claimed as confidential pursuant to Sec. 720.80, 
a sanitized copy must also be provided.
    (e) Agency or joint submissions. (1) A manufacturer or importer may 
designate an agent to submit the notice. Both the manufacturer or 
importer and the agent must sign the certification on the form.
    (2) A manufacturer or importer may authorize another person, (e.g., 
a foreign manufacturer or supplier, or a toll manufacturer) to report 
some of the information required in the notice to EPA on its behalf. If 
separate portions of a joint notice are not submitted together, the 
submitter should indicate which information will be supplied by another 
person and identify that person. The other person must submit the 
information on the appropriate part of the notice form. The manufacturer 
or importer and any other person supplying the information must sign the 
certification provided on their respective notice forms.
    (3) If EPA receives a submission which does not include information 
required by this rule, which the submitter indicates that it has 
authorized another person to provide, the notice review period will not 
begin until EPA receives that information.
    (f) New information. During the notice review period, if the 
submitter possesses, controls, or knows of new information that 
materially adds to, changes, or otherwise makes significantly more 
complete the information included in the notice, the submitter must that 
information to the address listed on the notice form within ten days of 
receiving the new information, but no later than five days before the 
end of the notice review period. The new submission must clearly 
identify the submitter and the notice to which the new information is 
related. If the new information becomes available during the last five 
days of the notice review period, the submitter must immediately inform 
its EPA contract for that notice by telephone.
    (g) Chemical substances subject to a section 4 test rule. (1) Except 
as provided in paragraph (g)(3) of this section, if (i) A person intends 
to manufacture or import a new chemical substance which is

[[Page 123]]

subject to the notification requirements of this part, and (ii) The 
chemical substance is subject to a test rule promulgated under section 4 
of the Act before the notice is submitted, section 5(b)(1) of the Act 
requires the person to submit the test data required by the testing rule 
with the notice. The person must submit the data in the form and manner 
specified in the test rule and in accordance with Sec. 720.50. If the 
person does not submit the test data, the submission is incomplete and 
EPA will follow the procedures in Sec. 720.65.
    (2) If EPA has granted the submitter an exemption under section 4(c) 
of the Act from the requirement to conduct tests and submit data, the 
submitter may not submit a notice until EPA receives the test data.
    (3) If EPA has granted the submitter an exemption under section 4(c) 
of the Act and if another person previously has submitted the test data 
to EPA, the exempted person may either submit the test data or provide 
the following information as part of the notice:
    (i) The name, title, and address of the person who submitted the 
test data to EPA.
    (ii) The date the test data were submitted to EPA.
    (iii) A citation for the test rule.
    (iv) A description of the exemption and a reference identifying it.
    (h) Chemical substances subject to a section 5(b)(4) rule. (1) If a 
person (i) intends to manufacture or import a new chemical substance 
which is subject to the notification requirements of this part and which 
is subject to a rule issued under section 5(b)(4) of the Act; and (ii) 
is not required by a rule issued under section 4 of the Act to submit 
test data for the substance before the submission of a notice, the 
person must submit to EPA data described in paragraph (h)(2) of this 
section at the time the notice is submitted.
    (2) Data submitted under paragraph (h)(1) of this section must be 
data which the person submitting the notice believes show that the 
manufacture, processing, distribution in commerce, use and disposal of 
the substance, or any combination of such activities, will not present 
an unreasonable risk of injury to health or the environment.

[48 FR 21742, May 13, 1983, as amended at 58 FR 34204, June 23, 1993; 60 
FR 16309, Mar. 29, 1995]