[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: 40CFR720.50]

[Page 125-127]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 720--PREMANUFACTURE NOTIFICATION--Table of Contents
 
                         Subpart C--Notice Form
 
Sec. 720.50  Submission of test data and other data concerning the health and environmental effects of a substance.

    (a) Test data on the new chemical substance in the possession or 
control of the submitter. (1) Except as provided in paragraph (d) of 
this section, each notice must contain all test data in the submitter's 
possession or control which are related to the effects on health or the 
environment of any manufacture, processing, distribution in commerce, 
use, or disposal of the new chemical substance or any mixture or article 
containing the new chemical substance, or any combination of such 
activities. This includes test data concerning the new chemical 
substance in a pure, technical grade, or formulated form.
    (2) A full report or standard literature citation must be submitted 
for the following types of test data:
    (i) Health effects data.
    (ii) Ecological effects data.
    (iii) Physical and chemical properties data.
    (iv) Environmental fate characteristics.
    (v) Monitoring data and other test data related to human exposure to 
or environmental release of the chemical substance.

[[Page 126]]

    (3)(i) If the data do not appear in the open scientific literature, 
the submitter must provide a full report. A full report includes the 
experimental methods and materials, results, discussion and data 
analysis, conclusions, references, and the name and address of the 
laboratory that developed the data.
    (ii) If the data appear in the open scientific literature, the 
submitter need only provide a standard literature citation. A standard 
literature citation includes author, title, periodical name, date of 
publication, volume, and page numbers.
    (4)(i) If a study, report, or test is incomplete when a person 
submits a notice, the submitter must identify the nature and purpose of 
the study; name and address of the laboratory developing the data; 
progress to date; types of data collected; significant preliminary 
results; and anticipated completion date.
    (ii) If a test or experiment is completed before the notice review 
period ends, the person must submit the study, report, or test to the 
address listed on the notice form, as specified in paragraph (a)(3)(i) 
of this section, within ten days of receiving it, but no later than five 
days before the end of the review period. If the test or experiment is 
completed during the last five days of the review period, the submitter 
must immediately inform its EPA contact for that notice by telephone.
    (5) For test data in the submitter's possession or control which are 
not listed in paragraph (a)(2) of this section, a person is not required 
to submit a complete report. The person must submit a summary of the 
data. If EPA so requests, the person must submit a full report within 
ten days of the request, but no later than five days before the end of 
the review period.
    (6) All test data described by paragraph (a) are subject to these 
requirements, regardless of their age, quality, or results.
    (b) Other data concerning the health and environmental effects of 
the new chemical substance that are known to or reasonably ascertainable 
by the submitter. (1) Except as provided in paragraph (d) of this 
section, any person who submits a notice must describe the following 
data, including any data from a health and safety study, if the data are 
related to the effects on health or the environment of any manufacture, 
processing, distribution in commerce, use, or disposal of the new 
chemical substance, of any mixture or article containing the new 
chemical substance, or of any combination of such activities:
    (i) Any data, other than test data, in the submitter's possession or 
control.
    (ii) Any data, including test data, which are not in the submitter's 
possession or control, but which are known to or reasonably 
ascertainable by the submitter. For the purposes of this section, data 
are known to or reasonably ascertainable by the submitter if the data 
are known to any of its employees or other agents who are associated 
with the research and development, test marketing, or commercial 
marketing of the substance.
    (2) Data that must be described include data concerning the new 
chemical substance in a pure, technical grade, or formulated form.
    (3) The description of data reported under this paragraph must 
include:
    (i) If the data appear in the open scientific literature, a standard 
literature citation, which includes the author, title, periodical name, 
date of publication, volume, and pages.
    (ii) If the data are not contained in the open scientific 
literature, a description of the type of data and summary of the 
results, if available, and the names and addresses of persons the 
submitter believes may have possession or control of the data.
    (4) All data described by this paragraph are subject to these 
requirements, regardless of their age, quality, or results; and 
regardless of whether they are complete at the time the notice is 
submitted.
    (c) [Reserved]
    (d) Data that need not be submitted--(1) Data previously submitted 
to EPA. (i) A person need not submit any data previously submitted to 
EPA with no claims of confidentiality if the notice includes the office 
or person to whom the data were submitted, the date of submission, and, 
if appropriate, a standard literature citation as specified in paragraph 
(a)(3)(ii) of this section.

[[Page 127]]

    (ii) For data previously submitted to EPA with a claim of 
confidentiality, the person must resubmit the data with the notice and 
any claim of confidentiality, under Sec. 720.80.
    (2) Efficacy data. This part does not require submission of any data 
related solely to product efficacy. This does not exempt a person from 
submitting any of the data specified in paragraph (a), (b), or (c) of 
this section.
    (3) Non-U.S. exposure data. This part does not require submission of 
any data which relates only to exposure of humans or the environment 
outside the United States. This does not exclude nonexposure data such 
as data on health effects (including epidemiological studies), 
ecological effects, physical and chemical properties, or environmental 
fate characteristics.

[48 FR 21742, May 13, 1983, as amended at 51 FR 15102, Apr. 22, 1986]