[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: 40CFR725.205]

[Page 490-491]
 
                   TITLE 40--PROTECTION OF ENVIRONMENT
 
         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)
 
PART 725--REPORTING REQUIREMENTS AND REVIEW PROCESSES FOR MICROORGANISMS
--Table of Contents
 
      Subpart E--Exemptions for Research and Development Activities
 
Sec. 725.205  Persons who may report under this subpart.

    (a) Commercial research and development activities involving new 
microorganisms or significant new uses of microorganisms are subject to 
reporting under this part unless they qualify for an exemption under 
this part.
    (b) Commercial purposes for research and development means that the 
activities are conducted with the purpose of obtaining an immediate or 
eventual commercial advantage for the researcher and would include:
    (1) All research and development activities which are funded 
directly, in whole or in part, by a commercial entity regardless of who 
is actually conducting the research. Indications that the research and 
development activities are funded directly, in whole or in part, may 
include, but are not limited to:
    (i) Situations in which a commercial entity contracts directly with 
a university or researcher; or
    (ii) Situations in which a commercial entity gives a conditional 
grant where the commercial entity holds patent rights, or establishes a 
joint venture where the commercial entity holds patent or licensing 
rights; or
    (iii) Any other situation in which the commercial entity intends to 
obtain an immediate or eventual commercial advantage for the commercial 
entity and/or the researcher.
    (2) Research and development activities that are not funded directly 
by a commercial entity, if the researcher intends to obtain an immediate 
or eventual commercial advantage. Indications that the researcher 
intends to obtain an immediate or eventual commercial advantage may 
include, but are not limited to:
    (i) The research is directed toward developing a commercially viable 
improvement of a product already on the market; or
    (ii) The researcher has sought or is seeking commercial funding for 
the purpose of developing a commercial application; or
    (iii) The researcher or university has sought or is seeking a patent 
to protect a commercial application which the research is developing; or
    (iv) Other evidence that the researcher is aware of a commercial 
application for the research and has directed the research toward 
developing that application.
    (c) Certain research and development activities involving 
microorganisms subject to jurisdiction under the Act are exempt from 
reporting under this part. A person conducting research and development 
activities which meet the conditions for the exemptions described in 
Secs. 725.232, 725.234, or 725.238 is exempt from TERA reporting under 
this subpart.
    (d) A microorganism is not exempt from reporting under subpart D of 
this part if any amount of the microorganism, including as part of a 
mixture, is processed, distributed in commerce, or used, for any 
commercial purpose other than research and development.
    (e) Quantities of the inactivated microorganism, or mixtures or 
articles containing the inactivated microorganism, remaining after 
completion of research and development activities may be disposed of as 
a waste in accordance with applicable Federal, State, and local 
regulations.

[[Page 491]]

    (f) A person who manufactures, imports, or processes a microorganism 
solely for research and development is not required to comply with the 
requirements of this section if:
    (1) The person is manufacturing a microbial pesticide identified in 
Sec. 172.45(c), or
    (2) The person is manufacturing a microbial pesticide for which an 
Experimental Use Permit is required, pursuant to Sec. 172.3; or
    (3) The person is manufacturing a microbial pesticide for which a 
notification or an Experimental Use Permit is not required to be 
submitted.