[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: 40CFR725.160]

[Page 488-489]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
  Subpart D--Microbial Commercial Activities Notification Requirements
 
Sec. 725.160  Submission of health and environmental effects data.

    (a) Test data on the new microorganism in the possession or control 
of the submitter. (1) Except as provided in Sec. 725.25(h), and in 
addition to the information required by Sec. 725.155(d)(3), each MCAN 
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 microorganism or any microbial mixture or article containing the 
new microorganism, or any combination of such activities. This includes 
test data concerning the new microorganism in a pure culture or 
formulated form as used or as intended to be used in one of the 
activities listed above.
    (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 new microorganism.
    (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 MCAN, 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 MCAN review 
period ends, the person must submit the study, report, or test, as 
specified in paragraph (a)(3)(i) of this section, to the address listed 
in Sec. 725.25(c) within 10 days of receiving it, but no later than 5 
days before the end of the review period. If the test or experiment is 
completed during the last 5 days of the review period, the submitter 
must immediately inform its EPA contact for that submission 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 10 
days of the request, but no later than 5 days before the end of the 
review period.
    (6) All test data described under paragraph (a) of this section are 
subject to these requirements, regardless of their age, quality, or 
results.
    (b) Other data concerning the health and environmental effects of 
the new microorganism that are known to or reasonably ascertainable by 
the submitter. (1) Except as provided in Sec. 725.25(h), and in addition 
to the information required by Sec. 725.155(c)(3), any person who 
submits a MCAN must describe the following data, including any data from 
a health and safety study of a microorganism, if the data are related to 
effects on health or the environment of any manufacture, processing, 
distribution in commerce, use, or disposal of the microorganism, of any 
microbial mixture or article containing the new microorganism, 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 microorganism.

[[Page 489]]

    (2) Data that must be described include data concerning the new 
microorganism in a pure culture or formulated form as used or as 
intended to be used in one of the activities listed in paragraph (b)(1) 
of this section.
    (3) The description of data reported under paragraph (b) of this 
section 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 available 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 in paragraph (b) of this section are subject 
to these requirements, regardless of their age, quality, or results; and 
regardless of whether they are complete at the time the MCAN is 
submitted.